Therapeutic Tooth Bud Ablation

ABSTRACT

Ablation probe tips ( 108, 148, 320, 360 ) and physical and virtual stents ( 110 ) for use in tooth bud ablation procedures that result in tooth agenesis as well as tooth bud ablation methods are described herein.

The present application is a continuation of U.S. patent applicationSer. No. 17/008,256, filed Aug. 31, 2020. U.S. patent application Ser.No. 17/008,256 is a divisional of U.S. patent application Ser. No.16/036,904, filed Jul. 16, 2018, issued as U.S. Pat. No. 10,765,490.U.S. patent application Ser. No. 16/036,904 is a continuation of U.S.patent application Ser. No. 14/849,431, filed Sep. 9, 2015, issued asU.S. Pat. No. 10,022,202. U.S. patent application Ser. No. 14/849,431 isa continuation of Patent Cooperation Treaty (PCT) Patent Application No.PCT/US2013/032357, filed Mar. 15, 2013. The present application is acontinuation of U.S. patent application Ser. No. 17/515,360, filed Oct.29, 2021. U.S. patent application Ser. No. 17/515,360 is a continuationof U.S. patent application Ser. No. 17/006,697, filed Aug. 28, 2020,issued as U.S. Pat. No. 11,173,012. U.S. patent application Ser. No.17/006,697 is a continuation U.S. patent application Ser. No.16/418,944, filed May 21, 2019. U.S. patent application Ser. No.16/418,944 is a continuation of U.S. patent application Ser. No.15/829,874, filed Dec. 2, 2017, issued as U.S. Pat. No. 10,298,255. U.S.patent application Ser. No. 15/829,874 is a continuation of U.S.application Ser. No. 14/849,464, filed Sep. 9, 2015, issued as U.S. Pat.No. 9,855,112. U.S. patent application Ser. No. 16/418,944 is acontinuation of U.S. patent application Ser. No. 15/215,020, filed Jul.20, 2016, issued as U.S. Pat. No. 10,335,248.

COPYRIGHT NOTICE

A portion of the disclosure of this patent document contains materialthat is subject to copyright protection. The copyright owner has noobjection to the facsimile reproduction of the patent disclosure as itappears in the Patent and Trademark Office patent files or records, butotherwise reserves all copyright rights whatsoever.

TECHNICAL FIELD

Described herein are a tooth bud ablation (TBA) procedure and a toothbud ablation (TBA) system.

BACKGROUND OF THE INVENTION

Approximately 3.5% of the total $100 billion spent on dental care in theUnited States in 2008 was for traditional surgical removal of thirdmolars (i.e. “wisdom teeth” extractions), including the associated costsof imaging, sedation, and resulting complications. Traditional surgicalremoval of third molars, however, is a highly invasive, painful, andcomplication-ridden procedure. Further, third molar extractionrepresents the only procedure in the United States and Europe where itis considered “normal” to subject patients of any age group to such ahighly invasive prophylactic surgery that carries significant lifelongrisks for the excision of asymptotic or non-pathologic tissue. Dentalpractitioners (e.g. general dentists, pediatric dentists, and oralsurgeons) have been trained to remove children's wisdom teeth (thirdmolars) before the wisdom teeth cause problems, but this surgery carriessignificant pain, risks and costs.

The main problem associated with third molar tooth extractions—asidefrom the pain inflicted—is the serious risk of complications associatedwith such an invasive procedure. Each year “more than 11 million patientdays of ‘standard discomfort or disability’—pain, swelling, bruising,and malaise—result post-operatively, and more than 11,000 people sufferpermanent paraesthesia—numbness of the lip, tongue, and cheek—as aconsequence of nerve injury during the surgery. At least two thirds ofthese extractions, associated costs, and injuries are unnecessary,constituting a silent epidemic of iatrogenic injury that afflicts tensof thousands of people with lifelong discomfort and disability.”

If you interview people under the age of 40 and ask them what has beenthe most invasive surgical procedure they have personally experienced(that is not trauma related), there is a greater than 90% chance that itwill be their “wisdom teeth” extraction. The current standard of care inAmerica for “managing” third molars (e.g. “wisdom teeth”) in adolescentsand young adults is generally to have all four third molars extractedonce they are formed, unless it is absolutely clear that these teethwill erupt normally. General dentists and oral surgeons alike arecomplicit in their belief that third molars generally should beextracted because not all will erupt normally, thus causing futurepathology.

Each year, an estimated 10 million third molar tooth extractions accountfor over 92% of all teeth extracted for patients under the age of 40.This represents surgery on approximately 5 million people each year atan estimated cost of over $2.5 billion for third molar extraction feesalone in the United States. When IV sedation fees, X-ray imagingexpenses, post-op medications, and unplanned post-operative expensesassociated with treating complications are added in, the true UnitedStates health care cost is estimated to be well over $3.5 billion. Inaddition to fee inflation, it has been shown that “upcoding” of wisdomteeth extraction (i.e. using an insurance code for payment of a higherfee than is clinically justified) has become an increasing problem forinsurers. Insurance claim patterns clearly show that this procedure islargely treated as an elective procedure. The average annual income peroral surgeon has been estimated to be approximately $500,000 for thirdmolar extraction fees alone. Insurance companies have historicallyreported that reimbursement for third molar extractions has been thehighest reimbursed surgical procedure—even higher than hysterectomies inyears when medical insurance used to pay for both procedures.

The market demographics and associated expenses are compelling. Over 77%of children at age 6 have all four third molar tooth budsradiographically detectable on routine panographic X-rays (a type ofvolume scan). Over 90% of all teenagers in the United States have atleast one third molar that will fully form. A typical cost for an oralsurgeon to remove all four third molars on a teenager is generally$2,000 to $2,500 per patient once the teeth have at least partiallyformed—but before they have erupted—including the cost of IV sedation,consultations, and X-ray imaging costs.

There has been considerable controversy for the past fifty yearsregarding prophylactic extraction of third molars. A number of leadingauthorities have objectively tried to demonstrate that prophylacticextraction is a waste of healthcare dollars, citing studies thatindicate there is no objective scientific evidence for such a procedure,while other groups vigorously argue that prophylactic extraction in theteens and early adult years greatly eliminates more serious problemslater in life and is worth the cost and risk.

An important question to ask is, “What happens if no prophylactic thirdmolar extractions occur?” For instance, “as many as 22% of all emergencydepartment visits” at a United States military support facility wererelated to dental problems, most of which were third-molar specific. Inthird-world countries, where prophylactic extraction of wisdom teeth issimply not performed, a high percentage of patients will present withacute infections, decay, gum disease and other problems later in life.In Jordan—where prophylactic extraction is not performed—46% of adultpatients had pathology (decay, infection, bone loss, etc.) detectable ontheir third molars on routine X-rays and volume scans. Numerous studiesshow that third molars are hard to clean, generally do not erupt fully,and are the single most-likely teeth to have problems associated withthem.

Routine panographic X-rays of adults taken during a random two-weekperiod are shown in FIGS. 1 and 2. These X-rays show the examples of therange of problems that adult patients experience when they have thirdmolars that are not extracted at an early age, including advanced decayand gum infections. For example, FIG. 1 shows a 48-year-old patient withboth upper third molars present. There is a gum infection around boththird molars that has caused 90% of the bone on the distal side of thesecond molars to be destroyed. In order to save the first molars,extraction of the second and third molars on the upper-arch will benecessary. FIG. 2 shows another example in which a 36-year-old patienthas all four third molars present. The upper third molars arehyper-erupting because they have no opposing teeth to occlude against.They will eventually need to be extracted. The lower third molars arehorizontally impacted and show no signs of infection, but if they becomeinfected, then the patient will almost certainly lose the adjacentsecond molars because of the bone damage that will occur.

The problem all practitioners face is that it is practically impossibleto tell in advance which impacted wisdom teeth will ultimately causefuture pathology. The reality is that most wisdom teeth (well over 50%)are surgically extracted prophylactically with no real knowledge thatthey will actually cause future pathology.

If pathology appears in patients over the age of 40, however, the stakesare much different. According to two prospective studies in the UnitedStates, in 1997 10.5% and in 2002 17.3% of patients requiring thirdmolar extractions were over the age of 40. If a patient is presentinglater in life to have one or more third molars extracted, it is becauseactive pathology has been diagnosed, making surgery no longer elective.The attendant complication rates are not just higher, but these patientswere categorized as “very high risk patients” for surgery. These studiesconcluded, “[t]he risk to patients and to the profession can bedramatically reduced by considering early removal of abnormal thirdmolars” and “based on our experience, we propose extraction of thirdmolars during adolescence when the X-ray indicates normal eruptioncannot be expected due to lack of space or an abnormal position.”

The occurrence of post-operative complications is generally consideredto be over 15% by most independent researchers. For instance, theformation of long-term periodontal pockets on the distal surfaces ofsecond molars that results in gum disease, infection, and eventualsecond molar tooth loss is estimated to be over 10% due to the damageand poor bone morphology that result from third molar extractionsurgery. The incidence of post-operative infections and “dry sockets” isgenerally accepted to be over 15%. Temporary paraesthesia due to damageto the mandibular nerve or the lingual nerve is over 10%, with residualpermanent numbness of the lip or tongue present in approximately 1.5% ofall patients. Recently, it has been concluded that approximately 23% ofall cases of long-term Temporomandibular Joint (“TMJ”) dysfunction andchronic joint pain are attributable to third molar extraction surgeries.

Malpractice claims against dental practitioners relating to third molarextractions are at an all time high. Litigation for residual TMJproblems is increasing; in 2002 a North Carolina jury awarded $5 millionin damages to a patient with TMJ pain following third molar extractions.The incidence of litigation over permanent numbness of the lip hasdramatically increased in recent years. Malpractice claims withresulting payouts have been reported to be as high as two-thirds of allclaims made against dental practitioners when nerve damage is involved.

If the wisdom teeth are not extracted in adolescence, the roots willfully form, making future extraction difficult and dramaticallyincreasing the incidence of serious complications if surgery shouldlater be required. The damage induced by long-standing, chronicinfections in adults may necessitate the extraction not only of thethird molars when they become symptomatic, but also of the adjacentsecond molars.

Additional complications include the reduced healing response of adultsas compared to adolescents, and the economic hardship induced by havingto miss work. Many references indicate that prophylactic extraction ofthird molars in teens and young adults—in spite of the possibility oflifelong complications such as nerve damage—is justified to avoid thenon-elective third molar extraction in adults over the age of 30.

Complications can be severe, even requiring hospitalization when teethhave been extracted on an out-patient basis. There have even beenreports of patients who died as a direct result of wisdom toothextractions.

As an example, FIG. 3 is an X-ray showing a 9-year-old patient with fourthird molar tooth buds present; three of them are in very early stagesof enamel formation. The lower right third molar tooth bud does not haveenamel formed yet, but will shortly. This X-ray shows an example of theearly stages in which the tiny third molar tooth buds begin to form,begin to develop enamel, and finally begin to develop roots. Early signsof problems are almost always clearly evident by the time a patient is ateenager.

Once the tooth starts to form, the tooth bud starts to become encased inbone and appears to be “pushed down” into the mandible and maxilla asthe child's jaw bone grows out and around the tooth bud with age. Futuresurgical access becomes far more invasive as the bone encases theforming third molar. Given the basic physiology involved, earlyintervention is the only approach that will eliminate the complicationsand high costs associated with extraction of fully formed third molarslater in life.

The idea of prophylactic third molar tooth bud removal is not new. In1936, Dr. Henry supported the surgical enucleation of tooth buds, and itwas again supported in the mid 70s by several practitioners usingsomewhat invasive surgical techniques to physically access the toothbuds and mechanically cut them out. In 1979, Drs. Gordon and Laskin usedcryoprobes to enucleate third molar tooth buds in dogs. However, at theNIH Conference On Third Molars in 1979 it was concluded that “[a]lthoughthere are cogent reasons for early removal of third molars, the groupfelt that the suggested practice of enucleation of third molar toothbuds, based on predictive studies at age 7 to 9, is not currentlyacceptable.” (National Institutes of Health—Removal Of Third MolarsConsensus Development Conference Statement—1979.)

Early removal of partially formed third molars (sometimes referred to asa “germectomy”) where the enamel of the crown has completely formed butless than one-third of the root length has formed, is demonstrated to besomewhat less invasive and carries no demonstrated long-termcomplications or risks associated with early-stage surgery. However, itis still highly invasive and generally requires IV sedation of theteenage patient. The American Association of Oral & MaxillofacialSurgeon's White Paper On Third Molar Data references five studiesinvolving over 1,100 germectomies with not a single case of a long-termcomplication (nerve injury, etc.) associated with the surgery. Further,since the germectomies were carried out on teenagers, there were noeconomic hardships induced by missing work. The White Paper understatesthe obvious conclusions associated with early intervention: “It doesappear that early third molar removal may be associated with a lowerincidence of morbidity and also less economic hardship from time offwork for the patient.” However, it can also be concluded that there wasa tremendous conflict of interest because this paper was written by oralsurgeons. To date there is still no measurable shift by dentalpractitioners to change the way in which third molars are screened,diagnosed, and extracted (i.e. early extraction), indicating that thereis a need to fundamentally change the way this condition is beingsurgically managed.

There are a number of existing alternative technical approaches that canbe considered for prophylactic enucleation of third molar tooth budsbefore the crown or root begins formation in children age 6 to 10. Thesetechnical approaches include ablation procedures using different typesof ablation means. Exemplary ablation procedures include microwaveablation, radio frequency ablation, irreversible electroporation,electrosurge tissue ablation (rats), cryoablation (dogs), laser ablation(dogs), and the use of a scalpel (humans). All but the first threeablation procedures have significant limitations due to being highlyinvasive, high in cost, requiring cumbersome equipment, or due to thelimited means of mechanical access in the oral cavity. Nor do theseablation procedures offer the potential for real-time feedback controlto contain collateral tissue damage. To date, the only documented trialof any form of tooth bud ablation procedure utilizing ablationtechnology that is currently used in mainstream medicine is cryoablation(although preliminary animal trials have been completed usingelectrosurgical power and lasers).

The article entitled “Selectively Preventing Development Of Third MolarsIn Rats Using Electrosurgical Energy” by Silvestri et al. describes apilot study that tests the hypothesis that third molars can beselectively prevented from developing. To test the hypothesis, a studywas conducted in which thirty-three neonate rats receivedelectrosurgical energy to the mucosal surfaces of one of their maxillarytuberosities. In this study, guides (insulating plastic positioningdevices that housed the electrosurgical probes) were used. The guideswere fabricated using the mouths of euthanized rat pups of the same ageas the rats that were to be treated as a mold for creating the guides.Then, the electrosurgical probe placed so that its stainless steel tipextended less than 1.0 mm beyond the plastic positioning device toensure contact with the external surface of the oral mucosa of themaxillary tuberosity. Finally, when in position, the rat pups received asingle, unilateral, momentary pulse of monopolar electrosurgical energyto the external surface of the gum tissue of their maxillary tuberosityregions. It should be emphasized that this surface application ofelectrosurgical energy acted first to unnecessarily kill the overlyinggum tissue, then bore a hole through the gum tissue, and otherwisedamage not only the tooth buds, but other nearby tissue. The rats werecared for, but after the experimental period, were euthanized todetermine the effectiveness of the procedure. The results were that tenrats showed no intra-oral or radiographic evidence of third molardevelopment (and most of these rats subsequently developed palataldeformities), and six developed smaller-than-normal third molars. Theconclusion was that maxillary third molars could be selectivelyprevented from developing in rat pups at or near the time of tooth budinitiation. It was recognized, however, that electrosurgical energy wastoo powerful and uncontrollable to reliably confine its damage to onlythe tooth-forming tissues.

U.S. Pat. No. 5,688,118 to Hayka et al. (the “Hayka reference”)discloses image, sound, and feeling simulation system for dentistry. Thesystem described in the Hayka reference can be thought of as a virtualsystem that may be used for implanting teeth. Such a virtual systemconnects the patient to the implant hand piece (i.e. “the drill”). Usingthree-dimensional scans on a display, the operator theoretically canguide movement of the drill bit relative to the patient for example, toallow the operator to guide the drill bit into the bone and place theimplant. The Hayka reference includes a dental hand piece having a drillfor drilling a cavity in a tooth, the drill having a drilling end; afirst three-dimensional sensor attached to the dental hand piece, thefirst three-dimensional sensor providing the system with position andorientation in space of at least the drill; and a data processing anddisplay unit for simulating at least the drilling end of the drill.Other patents and published patent applications that address aspects ofvirtual dentistry include U.S. Pat. No. 8,221,121 to Berckmans, III etal., U.S. Pat. No. 8,013,853 to Douglas, et al., U.S. Pat. No. 7,812,815to Banerjee, et al., U.S. Pat. No. 7,457,443 to Persky, U.S. Pat. No.7,249,952 to Ranta, et al., U.S. Patent Publication No. 20100316974 toYau, et al., U.S. Patent Publication No. 20100311028 to Bell, et al.,and U.S. Patent Publication No. 20090253095 to Salcedo, et al.

SUMMARY OF THE INVENTION

Disclosed herein is an ablation probe tip for use in a tooth budablation procedure that results in tooth agenesis. The ablation probetip may be used with a stent and an ablation probe unit. The ablationprobe tip preferably has a shaft and a center of ablation. The shaftpreferably has an insertion end for inserting into a tooth bud and aconnection end for connecting the ablation probe tip to the ablationprobe unit. The ablation probe tip preferably has a center of ablationbetween the insertion end and the connection end. The ablation probe tipmay be guidable at a pre-defined angle (preferably a three-dimensionalangle) when used in conjunction with the stent. The ablation probe tipmay be depth limited by stop information (stop indicator(s)) to apre-defined depth. The center of ablation substantially coincides withor overlaps with the middle of the tooth bud when the ablation probe tipis guided at the pre-defined angle to the pre-defined depth.

The stent may be a physical stent that has mechanical stop structure andthe ablation probe tip may have mechanical stop structure. The stopinformation in this situation would be a physical prevention ofprogression of the ablation probe tip provided by interaction of themechanical stop structures.

The ablation probe tip may have extension stop structure between thecenter of ablation and an absolute tip at the insertion end of theablation probe tip. The stop information in this situation would bephysical prevention of progression of the ablation probe tip provided byinteraction of the absolute tip with bone below or above the tooth bud.

The stent may be a virtual stent that has a display and the ablationprobe tip may be a sensored ablation probe tip. A representation of thesensored ablation probe tip may be displayed on the display. Thesensored ablation probe tip may be guidable at the pre-defined angle byvirtual surgical guide angle markings displayed on the display.

The pre-defined angle may be a three-dimensional angle and the stent maybe a virtual stent having a display. The ablation probe tip may be asensored ablation probe tip, and a representation of the sensoredablation probe tip may be displayed on the display, the sensoredablation probe tip may be guidable at the three-dimensional pre-definedangle by virtual surgical guide angle markings displayed on the display.

The stent may be a virtual stent that has a display and the ablationprobe tip may be a sensored ablation probe tip. A representation of thesensored ablation probe tip may be displayed on the display. The stopinformation (stop indicator(s)) in this situation would be provided by avirtual stop marking on the display.

The stent may be a virtual stent having a display and the hand piece maybe a sensored hand piece. A representation of the sensored hand piecemay be displayed on the display. The stop information (stopindicator(s)) in this situation would be provided by a virtual stopmarking on the display.

The stent may be a virtual stent, and the ablation probe tip may be asensored ablation probe tip. The stop information (stop indicator(s)) inthis situation would be provided by an indicator such as a visualindicator, an audible indicator, a tactile indicator, or a combinationof indicators.

The ablation probe tip preferably has a shaft inner conductor, shaftinsulation surrounding the shaft inner conductor, a shaft outer shieldsurrounding the shaft insulation, a window defined in the shaft outershield, a shaft outer cover surrounding the shaft outer shield and thewindow, and a reflector positioned between the window and the insertionend. The center of ablation is preferably positioned in the shaft innerconductor at the window, wherein the center of ablation is a focal point(focal area) from which ablation means radiates through the window.

The ablation probe tip preferably has a shaft inner conductor, shaftinsulation surrounding the shaft inner conductor, a shaft outer shieldsurrounding the shaft insulation, a window defined in the shaft outershield, a shaft outer cover surrounding the shaft outer shield and thewindow, and a deposited metal reflector positioned between the windowand the insertion end. The center of ablation is preferably positionedin the shaft inner conductor at the window, wherein the center ofablation is a focal point (focal area) from which ablation meansradiates through the window.

The ablation probe tip preferably has a shaft inner conductor, shaftinsulation surrounding the shaft inner conductor, a shaft outer shieldsurrounding the shaft insulation, a window defined in the shaft outershield, a shaft outer cover surrounding the shaft outer shield and thewindow, and a soldered reflector positioned between the window and theinsertion end. The center of ablation is preferably positioned in theshaft inner conductor at the window, wherein the center of ablation is afocal point (focal area) from which ablation means radiates through thewindow.

The ablation probe tip preferably has a shaft inner conductor, shaftinsulation surrounding the shaft inner conductor, a shaft outer shieldsurrounding the shaft insulation, a window defined in the shaft outershield, a shaft outer cover surrounding the shaft outer shield and thewindow, and an electroplated reflector positioned between the window andthe insertion end. The center of ablation is preferably positioned inthe shaft inner conductor at the window, wherein the center of ablationis a focal point (focal area) from which ablation means radiates throughthe window.

The ablation probe tip preferably has a shaft inner conductor, shaftinsulation surrounding the shaft inner conductor, a shaft outer shieldsurrounding the shaft insulation, a gap window defined in the shaftouter shield, a shaft outer cover surrounding the shaft outer shield andthe gap window, and a reflector positioned between the gap window andthe insertion end. The center of ablation is preferably positioned inthe shaft inner conductor at the gap window, wherein the center ofablation is a focal point (focal area) from which ablation meansradiates through the gap window.

The ablation probe tip preferably has a shaft inner conductor, shaftinsulation surrounding the shaft inner conductor, a shaft outer shieldsurrounding the shaft insulation, a gap window defined in the shaftouter shield, a shaft outer cover surrounding the shaft outer shield andthe gap window, and a deposited metal reflector positioned between thegap window and the insertion end. The center of ablation is preferablypositioned in the shaft inner conductor at the gap window, wherein thecenter of ablation is a focal point (focal area) from which ablationmeans radiates through the gap window.

The ablation probe tip preferably has a shaft inner conductor, shaftinsulation surrounding the shaft inner conductor, a shaft outer shieldsurrounding the shaft insulation, a gap window defined in the shaftouter shield, a shaft outer cover surrounding the shaft outer shield andthe gap window, and a soldered reflector positioned between the gapwindow and the insertion end. The center of ablation is preferablypositioned in the shaft inner conductor at the gap window, wherein thecenter of ablation is a focal point (focal area) from which ablationmeans radiates through the gap window.

The ablation probe tip preferably has a shaft inner conductor, shaftinsulation surrounding the shaft inner conductor, a shaft outer shieldsurrounding the shaft insulation, a gap window defined in the shaftouter shield, a shaft outer cover surrounding the shaft outer shield andthe gap window, and an electroplated reflector positioned between thegap window and the insertion end. The center of ablation is preferablypositioned in the shaft inner conductor at the gap window, wherein thecenter of ablation is a focal point (focal area) from which ablationmeans radiates through the gap window.

The ablation probe tip preferably has a shaft inner conductor, shaftinsulation surrounding the shaft inner conductor, a shaft outer shieldsurrounding the shaft insulation, an air gap window defined in the shaftouter shield, a shaft outer cover surrounding the shaft outer shield andthe air gap window, and a reflector positioned between the air gapwindow and the insertion end. The center of ablation is preferablypositioned in the shaft inner conductor at the air gap window, whereinthe center of ablation is a focal point (focal area) from which ablationmeans radiates through the air gap window.

The ablation probe tip preferably has a shaft inner conductor, shaftinsulation surrounding the shaft inner conductor, a shaft outer shieldsurrounding the shaft insulation, an air gap window defined in the shaftouter shield, a shaft outer cover surrounding the shaft outer shield andthe air gap window, and a deposited metal reflector positioned betweenthe air gap window and the insertion end. The center of ablation ispreferably positioned in the shaft inner conductor at the air gapwindow, wherein the center of ablation is a focal point (focal area)from which ablation means radiates through the air gap window.

The ablation probe tip preferably has a shaft inner conductor, shaftinsulation surrounding the shaft inner conductor, a shaft outer shieldsurrounding the shaft insulation, an air gap window defined in the shaftouter shield, a shaft outer cover surrounding the shaft outer shield andthe air gap window, and a soldered reflector positioned between the airgap window and the insertion end. The center of ablation is preferablypositioned in the shaft inner conductor at the air gap window, whereinthe center of ablation is a focal point (focal area) from which ablationmeans radiates through the air gap window.

The ablation probe tip preferably has a shaft inner conductor, shaftinsulation surrounding the shaft inner conductor, a shaft outer shieldsurrounding the shaft insulation, an air gap window defined in the shaftouter shield, a shaft outer cover surrounding the shaft outer shield andthe air gap window, and an electroplated reflector positioned betweenthe air gap window and the insertion end. The center of ablation ispreferably positioned in the shaft inner conductor at the air gapwindow, wherein the center of ablation is a focal point (focal area)from which ablation means radiates through the air gap window.

The pre-defined angle may be based on information obtained from a volumescan image. The pre-defined depth may be based on information obtainedfrom a volume scan image.

The ablation probe tip may be used for gaining access to the at leastone tooth bud without causing necrosis to surrounding gingival tissue.The ablation probe tip may be used for at least partially ablating atleast one tooth bud by creating a zone of ablation that resides onlywithin the at least one tooth bud. The ablation probe tip may be usedfor at least partially ablating at least one tooth bud without ablatingsurrounding gingival tissue. The ablation probe tip may be used for atleast partially ablating at least one tooth bud without ablatingsurrounding tissue.

The ablation probe tip may have a center of ablation is positionedwithin approximately 50% of an average diameter of the tooth bud whenthe ablation probe tip is at the pre-defined angle and the pre-defineddepth. The ablation probe tip may have a center of ablation ispositioned within approximately 25% of an average diameter of the toothbud when the ablation probe tip is at the pre-defined angle and thepre-defined depth. The ablation probe tip may have a center of ablationis positioned within approximately 10% of an average diameter of thetooth bud when the ablation probe tip is at the pre-defined angle andthe pre-defined depth.

An ablation probe tip may be used for use in a tooth bud ablationprocedure that results in tooth agenesis. The tooth bud preferably has amiddle. The ablation probe tip may be used with an ablation probe unit.The ablation probe tip may preferably has a shaft, the shaft preferablyhaving an insertion end for inserting into a tooth bud and a connectionend for connecting the ablation probe tip to the ablation probe unit.The ablation probe tip preferably has a center of ablation between theinsertion end and the connection end. The ablation probe tip preferablyhas a shaft inner conductor, shaft insulation surrounding the shaftinner conductor, a shaft outer shield surrounding the shaft insulation,a window defined in the shaft outer shield, a shaft outer coversurrounding the shaft outer shield and the window, and a reflectorpositioned between the window and the insertion end. The center ofablation is preferably positioned in the shaft inner conductor at thewindow. The center of ablation is preferably a focal point from whichablation means radiates through the window, the center of ablation maybe positionable to substantially coincide with or overlap with themiddle of the tooth bud.

The reflector may be a deposited metal reflector, a solder metalreflector, or an electroplated metal reflector. The window may be a gapwindow or an air gap window.

A virtual stent as described herein is preferably for use in a tooth budablation procedure that results in tooth agenesis. The tooth budpreferably has a middle. The virtual stent is preferably for use with asensored ablation probe tip having an insertion end and a connectionend. The sensored ablation probe tip preferably has a center of ablationbetween the insertion end and the connection end. The stent preferablyincludes a display upon which a representation of the sensored ablationprobe tip may be displayed. At least one virtual surgical guide anglemarking is preferably displayable on the display, the at least onevirtual surgical guide angle marking providing angle guidance to guidethe sensored ablation probe tip at a pre-defined angle. At least onevirtual stop marking is preferably displayable on the display providingstop information to limit the depth of the sensored ablation probe tipto a pre-defined depth. The center of ablation substantially coincideswith or overlaps with the middle of the tooth bud when the sensoredablation probe tip is guided at the pre-defined angle to the pre-defineddepth.

The pre-defined angle may be a three-dimensional angle. The virtualstent may be used with a sensored hand piece connectable to theconnection end of the sensored ablation probe tip. In such a case therepresentation of the sensored hand piece may be displayed on thedisplay. The three-dimensional volume scan may be displayed on thedisplay. The display may display a real time relationship between thecenter of ablation as compared to the middle of the tooth bud.

Stop information may be provided by an indicator selected from the groupconsisting of a visual indicator, an audible indicator, a tactileindicator, or a combination of indicators.

The pre-defined angle may be based on information obtained from a volumescan image. The stent pre-defined depth may be based on informationobtained from a volume scan image.

A tooth bud ablation method for ablating a tooth bud using a virtualstent may include the following steps: providing the virtual stent and asensored ablation probe tip; introducing the sensored ablation probe tipto the tooth bud, the introduction may be displayed in real time on thedisplay; using the at least one virtual surgical guide angle marking andthe at least one virtual stop marking; guiding the sensored ablationprobe tip towards the position where the center of ablationsubstantially coincides with or overlaps with the middle of the toothbud, the guidance may be displayed in real time on the display; andusing ablation means, ablating the tooth bud when the center of ablationsubstantially coincides with or overlaps with the middle of the toothbud.

The step of ablating preferably results in tooth agenesis.

The method may further include the step of setting parameters to be usedfor guiding the sensored ablation probe tip and for ablating the toothbud. The method may further include the step of calibrating the displayand the sensored ablation probe tip so that the sensored ablation probetip is properly represented on the display.

The method may further include the following steps: introducing asensored anesthetic needle to the tooth bud, the introduction may bedisplayed in real time on the display; using the at least one virtualsurgical guide angle marking and the at least one virtual stop marking;guiding the sensored anesthetic needle towards the middle of the toothbud, the guidance may be displayed in real time on the display; andanesthetizing the tooth bud when the sensored anesthetic needle reachesthe middle of the tooth bud.

The method may further including the step of providing visual, audible,and/or tactile indications to indicate that the center of ablationsubstantially coincides with or overlaps with the middle of the toothbud.

The method further includes the step of monitoring progress of theablating. Further, constant feedback pertaining to the progress may beprovided.

The method may include the step of providing monitoring and overridingsafeguards to allow automatic or manual cessation of ablation.

Described herein is an ablation probe tip for use in a tooth budablation procedure that results in tooth agenesis. The ablation probetip may be used with a surgical stent or a virtual stent system. Theablation probe tip may be used with an ablation probe unit. The ablationprobe tip has a shaft, the shaft having an insertion end for insertinginto a tooth bud and a connection end for connecting the ablation probetip to the ablation probe unit. The ablation probe tip has a center ofablation between the insertion end and the connection end. The shaft ofthe ablation probe tip being guidable at a pre-defined angle when usedin conjunction with the stent. The ablation probe tip has structure thatlimits the depth of the ablation probe tip to a pre-defined depth whenused in conjunction with the surgical stent; wherein the center ofablation is in the middle of a tooth bud when the ablation probe tip isat the pre-defined angle and the pre-defined depth.

Described herein is a tooth bud ablation procedure that results in toothagenesis, including the steps of: physically seating a custom surgicalstent having at least one surgical guide so the at least one surgicalguide corresponds to at least one tooth bud surgical site; using the atleast one surgical guide, making a surgical access path at the at leastone tooth bud surgical site; using the at least one surgical guide,guiding placement of an ablation probe tip having a center of ablationso that the center of ablation is in the middle of a tooth bud at the atleast one tooth bud surgical site; and at least partially ablating atleast one tooth bud.

Described herein is a tooth bud ablation system for use in a tooth budablation procedure that results in tooth agenesis, the system including:a custom surgical stent with at least one surgical guide correspondingto at least one tooth bud surgical site; an ablation probe tip having acenter of ablation; and the at least one surgical guide having structurefor guiding placement of the ablation probe tip so that the center ofablation is in the middle of a tooth bud by inserting the ablation probetip through the at least one surgical guide.

Described herein is an ablation procedure including the steps of:physically seating a custom surgical stent having at least one surgicalguide so the at least one surgical guide corresponds to at least onelesion or tumor surgical site; using the at least one surgical guide,making a surgical access path at the at least one lesion or tumorsurgical site; using the at least one surgical guide, guiding placementof an ablation probe tip having a center of ablation so that the centerof ablation is in the middle of a lesion or tumor at the at least onelesion or tumor surgical site; and at least partially ablating at leastone lesion or tumor.

Described herein is an ablation procedure including the steps of:physically seating a custom surgical stent having at least one surgicalguide so the at least one surgical guide corresponds to at least onelesion or tumor surgical site; using the at least one surgical guide,guiding placement of an ablation probe tip having a center of ablationso that the center of ablation is in the middle of a lesion or tumor atthe at least one lesion or tumor surgical site; and at least partiallyablating at least one lesion or tumor.

Described herein is a method for volume scanning both hard tissues andsoft tissues of a patient, the method including the steps of: using aphysical impression of a material visible in a volume scan; generating avolume scan in which hard tissue is visible and the physical impressionis visible, and soft tissue being “visible” as the space between thevisible hard tissue and the visible physical impression; and providingresults of the step of generating a volume scan for the purpose ofmanufacturing or fabricating a custom surgical stent having at least onesurgical guide for guiding placement of an ablation probe tip. Analternative method for volume scanning both hard tissues and softtissues of a patient replaces the physical impression with a digitalimpression.

Described herein is a method for simultaneous volume scanning of bothhard tissues and soft tissues, the method including the steps of: usinga physical dental impression of a material visible in a volume scan;physically seating the physical dental impression in a patient's mouth;volume scanning the patient's mouth while the physical dental impressionis seated therein; the step of volume scanning generating a volume scanin which hard tissue is visible and the physical dental impression isvisible, and soft tissue is “visible” as the space between the visiblehard tissue and the visible dental impression; and providing the resultsof the step of volume scanning for the purpose of manufacturing orfabricating a custom surgical stent having at least one surgical guidefor guiding placement of an ablation probe tip. An alternative methodfor volume scanning both hard tissues and soft tissues of a patientreplaces the physical dental impression with a digital impression.

Described herein is a method for manufacturing or fabricating a customsurgical stent, the method including the steps of: using a volume scanimage in which hard tissue is visible and a physical dental impressionis visible, and soft tissue is “visible” as the space between thevisible hard tissue and the physical visible dental impression; andmanufacturing or fabricating a custom surgical stent with at least oneablation probe tip guide for guiding at least one ablation probe tip toa pre-defined angle and depth of ablation based on information obtainedfrom the volume scan image. An alternative method for volume scanningboth hard tissues and soft tissues of a patient replaces the physicaldental impression with a digital impression.

Described herein is a tooth bud ablation procedure that results in toothagenesis, including the steps of: pre-operatively taking measurements todetermine a three-dimensional location of the middle of a tooth bud;placing an ablation probe tip having a center of ablation so that thecenter of ablation is in the three-dimensional location of the middle ofa tooth bud; and at least partially ablating at least one tooth bud.

Described herein is a custom surgical stent for use in a tooth budablation procedure that results in tooth agenesis, the custom surgicalstent for use with an ablation probe tip having a center of ablation,the stent including: a custom surgical stent with at least one surgicalguide corresponding to at least one tooth bud surgical site; the atleast one surgical guide having guiding structure to guide placement ofan ablation probe tip at a pre-defined angle so that a center ofablation of the ablation probe tip is in the middle of a tooth bud; andthe at least one surgical guide having mechanical stop structure tolimit the depth of the ablation probe tip to a pre-defined depth.

The foregoing and other objectives, features, and advantages of theinvention will be more readily understood upon consideration of thefollowing detailed description of the invention, taken in conjunctionwith the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are incorporated in and constitute a part ofthis specification.

FIG. 1 is an X-ray showing a 48-year-old patient with both upper thirdmolars present, the X-ray being presented to show examples of the rangeof problems that adult patients experience when they have third molarsthat are not extracted at an early age.

FIG. 2 is an X-ray showing a 36-year-old patient with all four thirdmolars present, the X-ray being presented to show examples of the rangeof problems that adult patients experience when they have third molarsthat are not extracted at an early age.

FIG. 3 is an X-ray showing a 9-year-old patient with four third molartooth buds present; three of them are in very early stages of enamelformation, but the lower right third molar tooth bud does not yet haveenamel formed.

FIG. 4 is a flow chart showing steps in preferred TBA proceduresincluding: (1) routine screening and diagnosis; (2) pre-surgicalimpressions and scanning; (3) assembling a TBA surgical kit; (4)operator delivery of the TBA procedure; and (5) follow-up.

FIG. 5 is a simplified block diagram of a TBA probe system, a customsurgical stent, and a tooth bud.

FIG. 6 is a cross-sectional side view of an ablation probe tip in theprocess of being inserted through a surgical guide of a stent.

FIG. 7 is a cross-sectional side view of an ablation probe tip insertedthrough a surgical guide of a stent into the tooth bud.

FIG. 8 is a cross-sectional side view of an ablation probe tip having alinear array of temperature sensors inserted in the tooth bud.

FIG. 9 is a cross-sectional side view of an ablation probe tip ablatingthe tooth bud.

FIG. 10 is a cross-sectional side view of an ablation probe tip beingremoved from the ablated tooth bud.

FIG. 11 is a flow chart showing the steps of a TBA procedure thatresults in tooth agenesis.

FIG. 12 is a flowchart showing the steps that a software program formanufacturing or fabricating custom surgical stents and defining (and/orcomputing or calculating) the pre-determined parameter settings and/ortreatment time settings.

FIG. 13 is a panographic X-ray showing a patient whose third molar toothbuds in the #17 and #32 positions are treatable by TBA.

FIG. 14 is a pre-operative cone beam computed tomography (“CBCT”) scanof a different patient.

FIG. 15 is a series of X-rays showing successive 1.0 mm slices throughboth #17 and #32 in 1.0 mm increments.

FIG. 16 is a perspective view from a front corner showing apre-operative upper-arch impression being taken of a simulated patient.

FIG. 17 is a cross-sectional view of an upper-arch impression beingtaken of a simulated patient.

FIG. 18 is a perspective view from above of the completed upper-archimpression.

FIG. 19 is a perspective view from above of the completed upper-archimpression, along with a stone model that will serve as a “positive” formanufacturing or fabricating of a custom surgical stent for thatpatient's upper-arch.

FIG. 20 is a CBCT scan with notations showing the measurement of theangle of entry into the tooth bud.

FIG. 21 is a series of X-rays with notations showing the measurement ofthe lateral angle of entry.

FIG. 22 is a CBCT scan with highlights showing the computed volume ofeach tooth bud.

FIG. 23 is a perspective view from above of a surgical stent with twosurgical guides, the stent having been manufactured or fabricated usingthe CBCT positioning information.

FIG. 24 is a perspective view showing topical anesthetic being appliedto the base of the surgical guide.

FIG. 25 is a perspective view from a front corner of a surgical stentbeing seated on the upper-arch of the simulated patient.

FIG. 26 is a perspective view from a front corner of a local anestheticbeing injected into a tooth bud site.

FIG. 27 is a perspective view from a front corner of a tissue trocarbeing used to punch to the base of a tooth bud.

FIG. 28 is a perspective view from a front corner of an ablation probetip with a mechanical (physical) stop being positioned through thesurgical guide into the tooth bud.

FIG. 29 is a perspective view from a front corner of the ablation probetip being positioned in each tooth bud through the surgical guide sothat the ablation probe tip's effective center of ablation is in themiddle of each tooth bud.

FIG. 30 is a cross-sectional side view of an alternative ablation probetip in the process of being inserted through a surgical guide of astent.

FIG. 31 is a cross-sectional side view of an alternative ablation probetip inserted through a surgical guide of a stent into the tooth bud.

FIG. 32 is a cross-sectional side view of an alternative ablation probetip having a linear array of temperature sensors inserted in the toothbud.

FIG. 33 is a cross-sectional side view of an alternative ablation probetip ablating the tooth bud.

FIG. 34 is a cross-sectional side view of an alternative ablation probetip being removed from the ablated tooth bud.

FIG. 35 is a simplified block diagram of a horizontal hand piece andablation probe tip with sensors and a display with a representation ofthe horizontal hand piece and ablation probe tip displayed thereon.

FIG. 36 is a simplified block diagram of a vertical hand piece andablation probe tip with sensors and a display with a representation ofthe vertical hand piece and ablation probe tip displayed thereon.

FIG. 37 is a simplified block diagram with an exemplary patient X-rayvolume scan shown on a display with a representation of the sensoredhand piece and ablation probe tip displayed as well as exemplaryindicators of position (in terms of percentage of the average diameterof the tooth bud) and status simultaneously shown on the display in realtime, the position shown as 98% (far from the middle of the tooth bud)and the status shown as inactive.

FIG. 38 is a simplified block diagram with an exemplary patient X-rayvolume scan shown on a display with a representation of the sensoredhand piece and ablation probe tip displayed as well as exemplaryindicators of position (in terms of percentage of the average diameterof the tooth bud) and status simultaneously shown on the display in realtime, the position shown as 8% (close to the middle of the tooth bud)and the status shown as active.

FIG. 39 is a simplified block diagram with an enlarged exemplary patientX-ray volume scan shown on a display with a representation of thesensored hand piece and ablation probe tip displayed as well as virtualsurgical guide angle markings, a virtual stop marking, and virtualtarget markings.

FIG. 40 is a flow chart showing exemplary steps in preferred TBAprocedures using a virtual stent system including: (1) ParameterSetting; (2) Calibrating; (3) Anesthetizing; (4) Introducing; (5)Guiding; (6) Readying; (7) Ablating; and (8) Completing.

FIGS. 41-43 are side and cross-sectional views of a first exemplaryablation probe tip.

FIGS. 44-46 are perspective and cross-sectional views of a secondexemplary ablation probe tip.

DETAILED DESCRIPTION OF THE INVENTION

The highly invasive surgical procedure of extracting third molars can becompletely eliminated by prophylactically eliminating the small toothbuds that will eventually form the wisdom teeth. Children age 6 to 12will generally have radiographically detectable tooth buds with no signsof tooth formation inside the tooth bud. Third molar tooth bud agenesis(the lack of third molar formation) can only be conclusively determinedby age 14. Third molar tooth buds are lying just 2.0 mm to 3.0 mmbeneath the surface of the attached gingival (gum) tissue, making themaccessible for rapid anesthesia and minimally invasive ablation with thecorrect selection of soft tissue ablation and supporting scanning andstent-manufacturing technologies.

By successfully improving existing medical technology, the highlyinvasive, painful, and complication-ridden procedure of traditionalsurgical removal of third molars (i.e. “wisdom teeth” extractions) canbe replaced with a minimally invasive tooth bud ablation (TBA) procedure70 such as that shown in FIG. 4 that is risk free, painlesspost-operatively, and less expensive when compared to surgicalextractions.

The TBA procedure 70 (FIG. 4) and TBA system 100 (FIG. 5) for use in theTBA procedure 70 seek to achieve: (1) a minimally invasive procedureconsisting of a surgical access path at a surgical site (e.g. at eachtooth bud surgical site), (2) that can predictably ablate all four thirdmolar tooth buds 120 in thirty (30) minutes or less (including time toadminister anesthesia) using either microwave (“MW”) or radio frequency(“RF”) ablation, (3) that can be administered by dental practitionersunder normal office conditions, (4) with direct procedure costs reducedby 25% or more, and (5) with zero risks or complications when comparedto traditional surgical extraction of fully developed third molars. Itshould be noted that the TBA procedure 70 is shown and described as aprophylactic third molar tooth bud ablation (TMTBA), but it is notlimited thereto. For example, there may be supernumerary teeth thatshould not be in a patient's mouth (e.g. there may be two teeth #5), theremoval of which would not be prophylactic in nature.

One preferred advantage of the surgical phase 90 described herein isthat it is a minimally invasive surgical procedure. With a minimallyinvasive surgical procedure design coupled with electronic feedbackcontrols using MW and RF ablation technology to limit soft tissuedamage, performing this procedure on children aged 6-12 years old takesapproximately thirty (30) (or fewer) minutes, including the time toadminister local anesthetics.

Another preferred advantage of the surgical phase 90 described herein isthat it will not accidentally disrupt adjacent second molar toothdevelopment, even though the formation of second molars are well underway because these tooth buds 120 have started to form before birth. Theuse of relatively new scanning technologies (e.g. computed tomographyvolume scanning such as cone beam computed tomography (CBCT) scanningand MRI volume scanning) and accurate custom surgical stents 110 toguide ablation probe tip 108, 148 placement will eliminate the risk ofaccidentally disrupting the second molars by minimizing collateraltissue damage.

Summarily, the TBA procedure 70 (FIG. 4) preferably includes a screeningphase 72, a pre-surgical phase 80 (also referred to as TBA pre-surgicalphase 80) that includes pre-surgical scanning 82 and the assembling of aTBA surgical kit 88 (that includes pre-determined settings 105 as wellas a surgical stent 110), a surgical phase 90 (also referred to as TBAsurgical phase 90), and a follow-up phase 98.

A TBA system 100 (FIG. 5) is preferably used during the surgical phase90 (shown graphically in FIGS. 6-10 and as a flow chart in FIG. 11) ofthe TBA procedure 70. Summarily, the TBA system 100 includes a TBA probesystem 101 (including a generator 104 capable of emitting one or moretypes of ablation means 104′, a hand piece 106, and an ablation probetip 108, 148) and at least one surgical stent 110 (which wasmanufactured or fabricated during the pre-surgical phase 80). Each stent110 has at least one surgical guide 112 to guide the placement of theablation probe tip 108, 148 so that its center of ablation 130 a isplaced into the middle of the tooth bud 130 b. This is accomplished bypositioning ablation probe tip 108, 148 through the surgical guide 112at a pre-defined angle and pre-defined depth (which may be done, forexample, using a mechanical relationship of the ablation probe tip 108and the surgical guide 112 to form a “stop” therebetween or in othermanners disclosed herein). FIGS. 6-10 show (and FIG. 11 describes) oneprocedure of inserting the ablation probe tip 108 through the surgicalguide 112 of a stent 110, ablating the tooth bud 120, and removing theablation probe tip 108 from the ablated tooth bud 120′. FIGS. 30-34 showan alternative procedure of inserting the alternative ablation probe tip148 through a surgical guide 112 of a stent 110, ablating the tooth bud120, and removing the ablation probe tip 108 from the ablated tooth bud120′. FIGS. 35-39 show a sensored ablation probe tip 232 for use with avirtual stent system. FIG. 40 shows an exemplary preferred TBA procedureusing a virtual stent system.

The TBA System 100

The TBA system 100 described herein is the system that is used duringthe surgical phase 90 of the TBA procedure 70. Some of the components(e.g. the custom surgical stent 110 and the pre-determined settings 105)used in the TBA system 100 are part of the TBA surgical kit assembledduring the pre-surgical phase 80.

The TBA system 100, as shown in FIG. 5, includes a TBA probe system 101(including a generator 104, a hand piece 106, and an ablation probe tip108, 148) and at least one surgical stent 110 (each stent 110 has atleast one surgical guide 112 to guide (direct) the placement of theablation probe tip 108, 148 to the middle of the tooth bud 130 b). Thegenerator 104 and the hand piece 106 may be jointly referred to as theablation probe unit 102 (or the programmable ablation probe unit 102).The generator 104 and hand piece 106 may be integral or functionallyconnected together. The generator 104 (and/or the ablation probe unit102) may be programmed with pre-determined parameter settings 105 aand/or treatment time settings 105 b (referred to jointly aspre-determined settings 105). The generator 104 (and/or the ablationprobe unit 102) provides an ablation means 104′ for ablating the toothbud 120 based on the pre-determined settings 105. Central to the TBAsystem 100, is the interaction between the ablation probe tip 108, 148and the surgical stents 110 (and specifically the surgical guides 112).

Generator 104

The generator 104 provides the ablation means 104′ suitable for ablatinga tooth bud 120 during the surgical phase 90 of the TBA procedure 70. MWenergy and RF energy are discussed as exemplary preferred ablation means104′. Another alternative preferred ablation means 104′ is irreversibleelectroporation because it has subsecond activation times that canreduce collateral tissue damage. Other alternative preferred ablationmeans 104′ include, but are not limited to, cryoablation, ultra-highintensity ultrasound, laser, chemical, thermal or hot tip (e.g. a tiphaving any source of heat including, but not limited to, a light bulb, asoldering iron, or steam heat), and/or mechanical means. These ablationmeans 104′ may also be combined either simultaneously or consecutively.It should also be noted that other known and yet-to-be-developedablation means 104′ may also be used. It should be noted that althoughdiscussed primarily in terms of MW and RF, unless specifically set forthotherwise, the use of other ablation means 104′ is possible.

The generator 104 (alone or as part of an ablation probe unit 102) maybe programmed by the operator and/or at the laboratory and/or factoryand may be accomplished automatically or manually. The programming ofthe generator 104 may include programming at least one pre-determinedsetting 105.

The following bulleted points are exemplary details and/or features thatmay be incorporated in preferred generators 104.

-   -   Preferred generators 104 may be multi-use devices designed as        110V counter-top units.    -   Preferred generators 104 may be MW/RF generators with output        levels determined initially through finite element analysis        models or experimentally derived functions that exist for tumor        ablation.    -   Preferred generators 104 (and/or ablation probe units 102) may        have operator input mechanisms (e.g. knobs, dials, key pads,        keyboards, I/O interfaces, connections to the internet, or other        means for inputting or programming) in which the operator inputs        (or allows input of) the pre-determined settings 105.    -   Preferred generators 104 (and/or ablation probe units 102) may        have output mechanisms (e.g. a display or audio) 103 for        providing setting feedback (e.g. calibration cycles and        pre-determined settings 105), warning feedback (e.g. to prevent        operator mishandling), and intra-operative feedback on the        progress of the procedure such as time remaining (e.g. a count        down or a series of beeps to alert the operator to procedure        completion) and/or temperature (e.g. to alert the operator to        overheating).    -   Preferred output displays may be digital readout displays (that        may be color and/or in a large format) that permit the operator        to easily see feedback intra-operatively from across a standard        dental operatory (approximately 6-8 feet viewing distance).

Hand Piece 106

The hand piece 106 is the functional intermediary between the generator104 and the ablation probe tip 108, 148. The hand piece 106 may beconnected substantially at one end to the generator 104. Substantiallyat the other end of the hand piece 106, opposite the generator 104, theend of the hand piece 106 (the surgical end) is adapted to accept theablation probe tip 108, 148. The hand piece 106 is preferably detachablefrom the generator 104 (if they are not an integral unit) and theablation probe tip 108, 148 (having an insertion end and a connectionend) is preferably detachable from the hand piece 106.

The following bulleted points are exemplary details and/or features thatmay be incorporated in preferred hand pieces 106.

-   -   Preferred hand pieces 106 preferably hold or secure an ablation        probe tip 108, 148 by latching the ablation probe tip 108, 148        into the hand piece head. In some hand pieces 106, the ablation        probe tip 108, 148 latches into the hand piece head at an angle        (e.g. a 90 degree angle). It should be noted that the terms        “latching” and “latch” are used to describe any type of secure        fit including, but not limited to, clipping, snapping, or        holding.    -   Preferred hand pieces 106 preferably have a hand piece head        (attached or integral) that is at an approximately 20 degree        angle to the rest of the hand piece. This bend emulates a        standard dental high-speed hand piece to facilitate easy access        of both upper and lower surgical sites. In some preferred hand        pieces 106, the 20 degree bend can be adjusted intra-operatively        to permit improved operator access to both upper and lower        arches.    -   Preferred hand pieces 106 preferably are rapidly detachable from        the generator 104. Preferably the connectors are ultra-reliable        for repeated removal/attachment from the generator 104.    -   Preferred hand pieces 106 are preferably fully steam        autoclavable. Alternative preferred hand pieces 106 are        disposable or have disposable covers.    -   Preferred hand pieces 106 preferably have actuators to allow        operator activation. The actuators may be separate from the hand        pieces 106 or integral therewith. Exemplary actuators include,        but are not limited to, a wireless foot control or a        hand-operated switch on the hand piece 106.    -   The hand piece 106 may be integral with the generator 104 to        form a hand-held integrated generator unit (hand-held integrated        ablation probe unit).

Ablation Probe Tips 108, 148

The ablation probe tip 108, 148 has a “shaft” having a connection endand an insertion end. The connection end has structure suitable forconnecting the ablation probe tip 108, 148 to the hand piece 106. Theinsertion end is insertable into the tooth bud 120. The ablation means104′ flows from the generator 104 through the ablation probe tip 108,148 and out to a center of ablation 130 a (the focal point of theablation). The ablation probe tip 108, 148 is insertable through thesurgical guide 112, through the gingival tissue 122, and into the middleof the tooth bud 130 b. Some ablation probe tips 108 have the center ofablation 130 a at or near the insertion end of the ablation probe tip108 such that when the insertion end of the ablation probe tip 108 ispositioned at the pre-defined angle (ϕ) and pre-defined depth (x) duringthe surgical phase 90, the center of ablation 130 a substantiallycoincides with or overlaps the middle of the tooth bud 130 b.Alternative ablation probe tips 148 have the center of ablation 130 afurther from the insertion end and along the shaft of the ablation probetip 148 such that when the center of ablation 130 a of the ablationprobe tip 148 is positioned so that the center of ablation 130 asubstantially coincides with or overlaps the middle of the tooth bud 130b.

The pre-defined angle (ϕ) is the angle at which the ablation probe tip'seffective center of ablation 130 a is in the “middle” of the tooth bud130 b as calculated (during the pre-surgical phase 80) as describedherein or using an alternative method. The pre-defined depth (x) is thedepth at which the ablation probe tip's effective center of ablation 130a is in the “middle” of the tooth bud 130 b as calculated as describedherein or using an alternative method. The phrase “middle of the toothbud 130 b” is meant to include the three-dimensional area within thetooth bud 120 and, in particular, the three-dimensional area within thetooth bud 120 that is more towards the absolute middle point thantowards the outer periphery of the tooth. The pre-defined angle (ϕ) andpre-defined depth (x) together define a three-dimensional (including anup/down dimension (depth (x)), a front/back dimension (y), and aside/side dimension (z)) path of insertion through which the ablationprobe tip 108, 148 accesses the gingival tissue 122 and the tooth bud120 so that the center of ablation 130 a substantially coincides with oroverlaps the middle of the tooth bud 130 b. The pre-defined angle (ϕ)and pre-defined depth (x) can also be referred to as the “calculatedangle and depth,” the “prescribed angle and depth,” the “proper angleand depth,” the “correct angle and depth,” the “optimal angle anddepth,” or the “ideal angle and depth.”

One preferred ablation probe tip 108 includes a mechanical stopstructure 140 (e.g. a band, protrusion, or shoulder) designed tophysically limit the depth of the ablation probe tip 108 when used inconjunction with mechanical stop structure 142 (e.g. the upper surface,a protrusion on the upper surface, or a notch in the upper surface) ofthe surgical stent 110 and/or surgical guide 112. In other words, themechanical stop structure 142 of the surgical guide 112 and themechanical stop structure 140 of the ablation probe tip 108 togetherlimit how much of the ablation probe tip 108 can pass through thesurgical guide 112 until there is a mechanical stop between themechanical stop structure 142 of the surgical guide 112 and themechanical stop structure 140 of the ablation probe tip 108. Thephysical prevention of further progression of the ablation probe tip 108provided by the interaction of the mechanical stop structures 140, 142is a type of “stop information,” the ablation probe tip 108 being depthlimited to the depth indicated by the stop information (which would bethe depth at which the center of ablation 130 a substantially coincideswith or overlaps with the middle of the tooth bud 130 b).

Each ablation probe tip 108 may be individually custom made (e.g.manufactured or fabricated) or may be selected from a family of ablationprobe tips 108 (i.e. there may be a “family” of probe tips 108 that willcover all clinical possibilities for tooth bud diameters and depths). Inthe manufacturing or fabricating of the surgical stents 110, however,the characteristics of the ablation probe tip 108 (custom made orselected) that may be taken into consideration include, for example,length, shape, angle, position of a mechanical stop structure 140,diameter, and size, shape, and location of the center of ablation 130 a.For example, if a particular ablation probe tip 108 had mechanical stopstructure 140 (shown as the bottom surface of an annular ring orshoulder in FIGS. 6-10 and 28-29) 10.0 mm from the absolute tip of theablation probe tip 108 (and the center of ablation 130 a issubstantially adjacent to the absolute tip), but the center of ablation130 a was only 8.0 mm from the surface of the gingival tissue 122 (shownas (x) in FIG. 6), then the surgical guide 112 would have to be 2.0 mmthick (shown as (y) in FIG. 6). On the other hand, if all surgicalguides 112 being made by the procedure were exactly 0.5 mm thick, theablation probe tip 108 would either have to be made or selected so thatthe mechanical stop structure 140 is 8.5 mm from the center of ablation130 a of the ablation probe tip 108. The appropriate ablation probe tip108 preferably will result in the intra-operative placement of theeffective center of ablation 130 a of the ablation probe tip 108 intothe targeted middle of the tooth bud 130 b±0.5 mm.

FIGS. 30-34 show an alternative ablation probe tip 148 with alternativestop structure 150 (shown as the portion of the alternative ablationprobe tip 148 between the center of ablation 130 a and the absolute tip152). The alternative stop structure 150 may also be referred to as“extension stop structure 150.” This alternative stop structure 150 usesthe bottom of the gingival tissue 122 (or the top of the bone upon whichthe tooth bud 120 is positioned) as the limiting structure used inconjunction with the alternative stop structure 150 to position thealternative ablation probe tip 148 at the proper pre-defined depth (x).(It should be noted that the “top of the bone” may be above or below thetooth bud 120 depending on whether the tooth bud is in the lower jaw orthe upper jaw.) Once the pre-defined depth (x) is calculated, thedistance (y) between the center of ablation 130 a and the bottom of thegingival tissue 122 (or the top of the bone upon which the tooth bud 120is positioned) can be measured and/or calculated. The alternative stopstructure 150 is an extension of the alternative ablation probe tip 148from the center of ablation 130 a and should be the same length as thedistance (y). In use, an alternative ablation probe tip 148 would beinserted through the surgical guide 112 of a surgical stent 110 at theproper pre-defined angle (ϕ), but would come to a stop when the absolutetip 152 touching the bottom of the gingival tissue 122 (or the top ofthe bone upon which the tooth bud 120 is positioned). In this position,the center of ablation 130 a would be the distance (y) from the bottomof the gingival tissue 122 (or the top of the bone upon which the toothbud 120 is positioned). The effective center of ablation 130 a targetedmiddle of the tooth bud 130 b would be substantially overlapping. Thephysical prevention of further progression of the ablation probe tip 148provided by the interaction absolute tip 152 touched the bottom of thegingival tissue 122 (or the top of the bone upon which the tooth bud 120is positioned) is a type of “stop information,” the ablation probe tip148 being depth limited to the depth indicated by the stop information(which would be the depth at which the center of ablation 130 asubstantially coincides with or overlaps with the middle of the toothbud 130 b).

These alternative ablation probe tips 148 may also be individuallycustom made (e.g. manufactured or fabricated) or may be selected from afamily of ablation probe tips 148 (i.e. there may be a “family” of probetips 148 that will cover all clinical possibilities for tooth buddiameters and depths). Although the surgical stent 110 is not used forlimiting structure to position the alternative ablation probe tip 148 atthe proper pre-defined depth (x), it is still used to guide thealternative ablation probe tip 148 in the proper pre-defined angle (ϕ).As previously set forth, the manufacturing or fabricating of thesurgical stents 110 may take into consideration the characteristics ofthe alternative ablation probe tip 148 (custom made or selected). Thecharacteristics that may be taken into consideration include, forexample, length, shape, angle, diameter, and position of the mechanicalstop structure 150. The size, shape, and location of the center ofablation 130 a of the alternative ablation probe tip 148 may also betaken into consideration in the manufacturing or fabricating of thesurgical stents 110. The alternative ablation probe tip 148 preferablywill result in the intra-operative placement of the effective center ofablation 130 a of the alternative ablation probe tip 148 into thetargeted middle of the tooth bud 130 b+0.5 mm.

It should be noted that for either type of ablation probe tip 108, 148,another variation would include either a movable center of ablation 130a or multiple centers of ablation 130 a. A movable center of ablation130 a variation would mean that the actual center of ablation 130 acould move up or down within the ablation probe tip 108, 148 for fineadjustments or for gross adjustments in position. The movability and/orposition of the center of ablation 130 a could be controlled by theoperator or automatically (e.g. by a computer). For example, if thealternative ablation probe tip 148 had a movable center of ablation 130a, the alternative ablation probe tip 148 would be inserted through thesurgical guide 112 of a surgical stent 110 at the proper pre-definedangle (ϕ), but would come to a stop when the absolute tip 152 touchedthe bottom of the gingival tissue 122 (or the top of the bone upon whichthe tooth bud 120 is positioned). The movable center of ablation 130 awould be moved to the distance (y) from the absolute tip 152 such thatthe effective center of ablation 130 a and the targeted middle of thetooth bud 130 b would be substantially overlapping.

A multiple centers of ablation 130 a variation would mean that therewould be more than one center of ablation 130 a within the ablationprobe tip 108, 148. Which of the multiple centers of ablation 130 a wasused for a particular tooth bud could be controlled by the operator orautomatically (e.g. by a computer). For example, if the alternativeablation probe tip 148 had multiple centers of ablation 130 a, thealternative ablation probe tip 148 would be inserted through thesurgical guide 112 of a surgical stent 110 at proper pre-defined angle(ϕ), but would come to a stop when the absolute tip 152 touched thebottom of the gingival tissue 122 (or the top of the bone upon which thetooth bud 120 is positioned). Which of the multiple centers of ablation130 a would be actuated would be determined by which center of ablation130 a was the closest to the distance (y) from the absolute tip 152 suchthat the effective center of ablation 130 a and the targeted middle ofthe tooth bud 130 b would be substantially overlapping.

The ablation probe tips 108, 148 may be sharp enough and/or may bestrong enough so that the ablation probe tips 108, 148 can be“self-introducing” in that the ablation probe tips 108, 148 can bepushed through the gingival tissue 122. Alternatively, if tissue trocars146 (described herein) are to be used, the ablation probe tips 108, 148would not have to be as sharp and/or strong.

The following bulleted points are exemplary details and/or features thatmay be incorporated in preferred ablation probe tips 108, 148.

-   -   Preferred ablation probe tips 108, 148 are preferably disposable        (e.g. single-use).    -   Preferred ablation probe tips 108, 148 may be specially designed        to work with the specific ablation means 104′ produced by the        generator 104. Other preferred ablation probe tips 108, 148 may        be designed to work with multiple types of ablation means 104′        produced by the generator 104 or generators 104.    -   The design of the ablation probe tip 108, 148 may be dependent        on the physics involved with transmitting ablation means 104′        through the smallest possible diameter with an ideal maximum        diameter. For example, an MW/RF ablation probe tip may be        designed for transmitting MW/RF energy through the smallest        possible diameter with an ideal maximum diameter of 0.5 mm to        1.0 mm targeted.    -   The “family” of probe tips 108, 148 may include probe tips 108,        148 having a variety of characteristics. For example, the family        might have probe tips 108, 148 of different lengths ranging from        5.0 mm to 25.0 mm. This range would accommodate the various        diameters of the tooth buds 120 and overlying gingival tissue        122 thicknesses.    -   Intra-operative temperature sensing (shown as being performed by        a linear array of temperature sensors 144 in FIG. 8) is        preferably provided at or near the apex of the ablation probe        tip 108, 148 (assuming placement in the ideal middle of the        tooth bud 130 b) and/or along the shaft 145 of the probe tip        108, 148. Temperature sensors 144 provide core temperatures for        feedback control purposes (so that the operator can monitor the        temperature and/or for software feedback control loops and        emergency shutdown) and/or for safety controls to reduce or        eliminate collateral tissue damage. Intra-operative tissue        temperature is preferably measured, both to assure complete        ablation and to prevent over-heating of tissues; this may        require additional set up data or programming. If temperature        sensors 144 are used, the appropriate ablation probe tip 108,        148 preferably will result in the intra-operative placement of        the effective center of ablation 130 a of the ablation probe tip        108, 148 into the targeted middle of the tooth bud 130 b±1.0 mm.

FIGS. 41-46 show specific exemplary ablation probe tips 320, 360 (thatcould be constructed as ablation probe tip 108 or ablation probe tip148) that would work in the TBA systems 100 discussed herein. Eachexemplary ablation probe tip 320, 360 has a shaft with a connection end322 a, 362 a (shown as a female SMA connector for connecting directly orindirectly to a generator 104 via a hand piece 106) and an insertion end322 b, 362 b (for inserting into the tooth bud 120). These exemplaryablation probe tips 320, 360 have microwave ablation means (e.g.microwave energy, waves, and/or radiation) that flow from the generator104 to and through the exemplary ablation probe tip 320, 360 (from theconnection end 322 a, 362 a towards the insertion end 322 b, 362 b, andreflecting back from a reflector 326, 366) and to a center of ablation130 a (the focal point of the ablation) from which it radiates throughthe window 328, 368. The shown exemplary ablation probe tips 320, 360preferably include “structure for transmitting microwave ablation means”324, 364 and a reflector 326, 366. The structure for transmittingmicrowave ablation means 324, 364 may be a coaxial cable (coax cable)324, 364 or other structure having an inner conductor 324 a, 364 a (alsoreferred to as a center core), insulation 324 b, 364 b (e.g. adielectric insulator such as polytetrafluoroethylene (PTFE)) surroundingthe inner conductor, an outer conductor or shield 324 c, 364 c (e.g. ametallic or copper annular layer) surrounding the insulation, and anoptional outer sheath, protector, or cover 324 d, 364 d (the outer coveris “optional” in that it may be distinct from the main “coaxial cable”so that it is added in a separate step) surrounding the outer shield.Microwave ablation means that “hit” the reflector 326, 366 bounce(reflect) back up the coax cable 324, 364 creating two “signals” (theincoming microwave ablation means and the reflected microwave ablationmeans). Put another way, the reflector 326, 366 creates an electricallyconductive end treatment between the inner conductor 324 a, 364 a andthe outer conductor or shield 324 c, 364 c such that the inner conductor324 a, 364 a and the outer conductor or shield 324 c, 364 c act likereflector surfaces that redirect the microwave to create the standingwave. A 360 degree opening or window 328, 368 is positioned near theinsertion end 322 b, 362 b (shown as approximately 2 mm from theinsertion end 322 b, 362 b). The reflector 326, 366 allows the microwaveablation means to create a standing wave as the two signals (theincoming and reflected) interact through interference patterns and areefficiently radiated laterally (90 degrees) to the coax cable 324, 364.The center of ablation 130 a is located at least substantially centeredin the coax inner conductor 324 a, 364 a at the point where it issurrounded by the window 328, 368.

FIGS. 41-43 show first exemplary ablation probe tips 320 having aconnection end 322 a and an insertion end 322 b. FIGS. 44-46 show asecond exemplary ablation probe tip 360 having a connection end 362 aand an insertion end 362 b. The first and second exemplary ablationprobe tips 320, 360 have many similar features. Both the first and thesecond exemplary ablation probe tips 320, 360 include a coax cable 364(or structure equivalent thereto), a reflector 326, 366, and a gapwindow 328, 368 (shown as being approximately 1 mm). The gap window 328,368 is created by removing (by known removal methods) a portion of thecoax outer shield 324 c, 364 c. The coax outer shield 324 d, 364 dcovers the coax outer shield 324 c, 364 c, but leaves a gap where thecoax outer shield 324 c, 364 c has been removed. The outer cover 324 d,364 d forms the point or sharp edge of the insertion end 322 b, 362 b.The outer cover 324 d, 364 d may be a molded sheath made from a polymermaterial having properties such as strength, hardness,injection-moldability, slipperiness, ability to hold a sharp point,and/or radiolucency (transparency to microwave energy) such as, forexample, PEEK, Ultem, Nylon, and/or Polycarbonate.

As mentioned, both the first exemplary ablation probe tip 320 and thesecond exemplary ablation probe tip 360 include a gap window 328, 368.An air gap window has proven to be effective and economically efficientand, therefore would be suitable for either the first exemplary ablationprobe tip 320 or the second exemplary ablation probe tip 360.Alternative gap windows 328, 368 could be made of any material that issufficiently transparent to the microwave radiation and has theappropriate mechanical properties. One exemplary alternative to the airgap window is a ceramic gap window.

One difference between the first exemplary ablation probe tips 320 andthe second exemplary ablation probe tip 360 is the specific shownreflector 326, 366. FIGS. 41-43 show first exemplary ablation probe tips320 having a soldered reflector 326. FIGS. 44-46 show a second exemplaryablation probe tip 360 having a “deposited” reflector 326. A depositedreflector may have many different types of depositions resulting fromdeposition techniques including, but not limited to, “electroplating”techniques, “electroless” plating techniques, mechanical application ofparticulate techniques, “plasma deposition” techniques, “ion beamimplantation” techniques, “sputter coating” techniques, “vacuumdeposition” techniques, and any known or yet to be discovered techniquefor depositing a surface that is sufficiently electrically conductive toserve as a reflector directly to the surface of the coax cable. Itshould be noted that although the first exemplary ablation probe tip 320is shown as having a soldered reflector 326, it could have a depositedreflector. Similarly, although the second exemplary ablation probe tip360 is shown as having a deposited reflector 326, it could have asoldered reflector. Replacing expensive components (e.g. machined metalreflectors) with more economical alternatives (e.g. soldered,electroplated, or otherwise deposited reflectors) significantly reducedmanufacturing time (plating being suitable to large scale automatedprocessing) and the resulting exemplary ablation probe tips 320, 360worked as well or better than more complicated and expensive versions.

There are also superficial differences such as the shape. For example,the first exemplary ablation probe tip 320 is straight and the secondexemplary ablation probe tip 360 is angled. Another superficialdifference is the presence in the second exemplary ablation probe tip360 of an overmolded support 372 that is added to the exterior of thecoax cable 364.

It should be noted that FIGS. 41-46 show specific exemplary ablationprobe tips 320, 360. Dimensions and angles specified thereon (eitherwritten, measurable, or implied) are for purposes of enablement of thesespecific exemplary ablation probe tips. They are not meant to limit thescope of the invention. Further, specific features of two of theexemplary ablation probe tips may be used to create additional exemplaryablation probe tips. The specific materials and shapes of the exemplaryablation probe tips 320, 360 and the style/dimensions of the puncturingportion of the ablation probe tip (the insertion end 322 b, 362 b) maybe adapted for a particular intended use without affecting the scope ofthe invention.

Stent 110

The at least one custom surgical stent 110 (also referred to as a “stent110” or a “surgical stent 110”) has at least one surgical guide 112(also referred to as “guides 112” or “ablation probe tip guides 112”).Two surgical stents 110 would be used, for example, if both upper andlower tooth buds 120 were to be ablated. The surgical stents 110 aredesigned to seat in a patient's mouth and may be supported by at leastone tooth (a tooth-supported surgical stent), soft tissue (a softtissue-supported surgical stent), and/or bone (a bone-supported surgicalstent). If the surgical stent 110 is supported by more than one ofthese, it could be considered a combination-supported surgical stent.Preferred surgical stents 110 may “snap” into the mechanical undercutsinherent in the patient's erupted teeth. A surgical stent 110 would havemore than one surgical guide 112 if more than one tooth bud were to beablated on either the upper or lower jaw.

The surgical stents 110 and the guides 112 therein are used to controlone or both of the pre-defined angle (ϕ) and the pre-defined depth (x)of the ablation probe tip 108, 148 in order to assure that the ablationprobe tip's effective center of ablation 130 a is in the middle of thetooth bud 130 b±0.5 mm. The pre-defined angle (ϕ) is primarilycontrolled by the angle of the surgical guides 112 (the passagewaysthrough the stent 110). For some types of ablation probe tips 108, thepre-defined depth (x) is primarily controlled by the interaction betweenthe mechanical stop structure 142 of the surgical stent 110 (and/orsurgical guide 112) and the mechanical stop structure 140 of theablation probe tip 108. For other types of ablation probe tips 148, thepre-defined depth (x) is primarily controlled by the interaction betweenthe alternative stop structure 150 and the bottom of the gingival tissue122 (or the top of the bone upon which the tooth bud 120 is positioned).The operator inserts the ablation probe tip 108, 148 at the entry angle(ϕ) defined by the guide 112 and to the depth (x) limited by theappropriate mechanical stop structure.

The surgical guides 112 are passageways through the surgical stent (thepassageways being a type of guiding structure). The pre-defined angle(ϕ) for each passageway (guide 112) is determined by the position of themiddle of the tooth bud 130 b. For example, if the middle of the toothbud 130 b is “slightly forward” the angle (ϕ) of the passageway (guide112) would be “slightly forward” so that the ablation probe tip 108, 148is angled “slightly forward” so that the center of ablation 130 a ispositioned substantially at the middle of the tooth bud 130 b. The angle(ϕ) of the passageway is determined (e.g. calculated) by the softwarebased upon tooth bud volumes determined in pre-surgical volume scanning82. In addition to providing a path through which the ablation probe tip108, 148 accesses the gingival tissue and the tooth bud, the guides 112may also be used to provide access for administering local anestheticand to provide access to a tissue trocar 146 (if necessary).

In the shown preferred example, the mechanical stop structure 142 is theupper surface of the surgical stent 110 and/or surgical guide 112. Themechanical stop structure 142 is substantially adjacent to or near thesurgical guide 112. The mechanical stop structure 142, however, could bepositioned at locations of the surgical stent 110 beyond the surgicalguide 112. Alternative preferred mechanical stop structure 142 includesa protrusion on the upper surface or a notch in the upper surface. Thesize and shape of the mechanical stop structure 142 is determined(calculated or designed) by a process that may be implemented assoftware or as a program and is based upon tooth bud volumes determinedin pre-surgical volume scanning 82 as well as the length between theablation probe tip mechanical stop structure 140 and its center ofablation 130 a. For example, if the middle of the tooth bud 130 b is 2.5mm below the surface (determined in pre-surgical volume scanning 82),and the available ablation probe tips 108 have a length (between theirrespective mechanical stop structure 140 and its center of ablation 130a) of 2.4 mm and 2.6 mm, the process (that may be implemented bysoftware or a program) would determine that the 2.6 mm ablation probetip 108 is the appropriate ablation probe tip 108 (the 2.4 mm ablationprobe tip 108 being too short), but that the surgical stent 110 and/orsurgical guide 112 would have to be approximately 0.1 mm thick to makeup the difference or the 2.6 mm ablation probe tip 108 would be able tobe pushed in too far.

FIG. 12 is a flowchart showing the steps of a process (that may beimplemented as one or more software programs or subprograms if the shownsteps are divided) that, in part, determines the pre-defined angle (ϕ)and the pre-defined depth (x) (see steps 200, 210, 212, 214, 216, and218). Using this process, patient volume scans are used to accuratelymanufacture or fabricate custom surgical stents 110 with the correctablation probe tip angle (ϕ) and depth (x) manufactured into them. Morespecifically, using this process with the volume scans will permitaccurate placement of the distal surgical guides 112 onto the customsurgical stents 110 so that both angle (ϕ) of insertion and depth (x) ofinsertion of the ablation probe tip 108, 148 are controlled to ±0.5 mm,placing the ablation probe tip's effective center of ablation 130 a inthe middle of the tooth bud 130 b.

The following bulleted points are exemplary details and/or features thatmay be incorporated in preferred stents 110.

-   -   Preferred surgical stents 110 are preferably disposable (e.g.        single-use).    -   Manufacturing or fabricating of the custom surgical stents 110        may be based upon physical (e.g. Poly Vinyl Siloxane (PVS)) full        arch impressions of the patient's erupted teeth using either        conventional lab fabrication techniques or direct-digital        manufacturing (including digital impressions) or fabricating        techniques. If an operator has a CBCT unit in his office, it may        be possible to directly scan the physical (PVS) impressions and        email the volume scan of the impression to eliminate the need to        physically send them to the lab. The impression materials may        include materials other than PVS and preferably will be        contrast-optimized through the addition of X-ray contrast agents        (such as barium or iodine) to provide optimized volume scans of        the dental impression for resolving the fine surface detail of        the teeth and gingival tissue 122. This unique material would be        a radiographic contrast-optimized dental impression material for        high resolution X-ray CT volume scanning. An alternative method        for volume scanning replaces the physical impression with a        digital impression.    -   Preferred surgical stents 110 are preferably made of any        appropriate material including, but not limited to, plastic,        acrylic, or other nontoxic sturdy material suitable for use in a        patient's mouth. One exemplary surgical stent 110 composition        may be, for example, clear acrylic (polymethyl methacrylate). It        should be noted that materials suitable for additive-type        manufacturing (or other direct-digital manufacturing or        fabricating techniques) that resulted in nontoxic sturdy stents        would be preferable.    -   Preferred surgical stents 110 preferably have markings such as        color codes or numbering clearly marking or identifying the        tooth bud numbering sites.    -   Once the surgical stent 110 is seated onto the patient's teeth,        it preferably will remain firmly in place throughout the        surgical phase 90 of the TBA procedure 70.    -   The operator may administer local anesthetic through the guides        112.

Pre-Determined Settings 105

The pre-determined settings 105 include, for example, pre-determinedparameter settings 105 a and/or treatment time settings 105 b that areneeded to control (provide instructions to) the generator 104 (alone oras part of an ablation probe unit 102) to provide sufficient ablationmeans 104′ to ablate the tooth bud 120, but not so much as to incursignificant collateral soft tissue damage (e.g. to the gingival tissue122). For example, the pre-determined parameter settings 105 a mightcontrol the quantity and quality ablation means 104′ delivered to thetooth bud 120. The actual pre-determined parameter settings 105 a willbe highly dependent on the type of ablation means 104′ to be delivered.For example, MW and RF ablation means might have parameters relating towavelength and/or frequency, hot tip ablation means might haveparameters relating to temperature, chemical ablation means might haveparameters relating to the strength of the chemical and how fast thechemical is flowing into the tooth bud, and mechanical ablation meansmight have parameters relating to speed.

The pre-determined settings 105 are determined (which includescomputing, calculating, looking up, processing, or otherwisedetermining) by a process (that may be implemented as software or aprogram) based upon tooth bud volumes determined in pre-surgical volumescanning 82. It should be noted that the pre-determined settings 105 maytake into consideration factors other than tooth bud volume including,but not limited to, image recognition programs to measure tooth budlocation, age and size of the patient, and other relevant factors tosuccessfully image the patient for the TBA procedure 70. FIG. 12 is aflowchart showing the steps of a process (that may be implemented as oneor more software programs or subprograms if the shown steps are divided)that, in part, determine the pre-determined parameter settings 105 aand/or treatment time settings 105 b (see steps 200, 220, 222, and 224).

The generator 104 (and/or the ablation probe unit 102) may be programmedby the operator and/or technicians at the laboratory and/or factory. Theprogramming may be automatic or manual. “Programming” includes havingthe pre-determined settings 105 pre-entered and/or entering (inputting)the pre-determined settings 105 manually or automatically into thegenerator 104 (and/or the ablation probe unit 102) via operator inputmechanisms. For example, the pre-determined settings 105 may bepreprogrammed into an ablation probe unit 102, transmitted to theoperator in the form of a programming signal (e.g. over the internet tobe downloaded and installed in the ablation probe unit 102 or thegenerator 104), provided in the form of computer-readable media (e.g. adisc or a solid state USB drive), and/or provided as data (or a code)that may be manually entered into the ablation probe unit 102 (or thegenerator 104). Ideally, whichever method of entering/programming theablation probe unit 102 (or the generator 104) is used, operator erroris considered and eliminated as much as possible and appropriate checksare used. Preprogramming and some of the other means for programming theablation probe unit 102 (or the generator 104) with the pre-determinedsettings would help to eliminate operator input errors. Another exampleof means for eliminating errors is that even if the ablation probe unit102 (or the generator 104) is preprogrammed by the laboratory, thepre-determined settings might be displayed to the operator forindependent “verification” as the operator could notice variations fromnormal pre-determined settings (e.g. the literature provided mightprovide a range and the operator would notice if the providedpre-determined settings 105 fell outside of the range). Yet anotherexample is that the pre-determined settings might be provided as a codethat, when input, would only function if it corresponded with a logicalsetting (e.g. if the person's age was also input into the ablation probeunit 102 and the code was not a logical setting based on the age, theablation probe unit 102 would not function).

The pre-determined settings 105 for each TBA site may be included in theTBA surgical kit as a print out, on a disk or other computer readablestorage media, or with instructions on how to obtain or download theinformation.

The pre-determined ablation means parameter settings 105 a can also bereferred to as “parameter settings 105 a,” “preferred parameter settings105 a,” “optimal parameter settings 105 a,” “ideal parameter settings105 a,” “pre-determined parameter settings 105 a,” “recommendedparameter settings 105 a,” or “prescribed parameter settings 105 a.”

Tissue Trocar 146

If the ablation probe tip 108, 148 is not self-introducing, at least onesharp instrument (that is preferably disposable) such as a tissue trocar146 (and sometimes a plurality of tissue trocars) may be used by theoperator to introduce (initially create) the access opening through thethick attached gingival tissue 122 that overlays third molar tooth buds120. The tissue trocar tips are preferably sharp enough to be pushedand/or punched through the gingival tissue 122 into the base of thetooth bud. The diameter of the tissue trocar 146 rapidly increases up to100% of the size of the ablation probe tip 108, 148. After the tissuetrocar 146 has created the access opening, the tissue trocar 146 isremoved and the ablation probe tip 108, 148 is immediately placed intothe access opening.

TBA Surgical Kit

The TBA surgical kit is a package that includes the majority of thenecessary components and information for the surgical phase 90 of theTBA procedure 70. The TBA kit will be assembled (or the assembly will becompleted) based on the patient's impressions and volume scans.Preferably the TBA surgical kit has attractive packaging.

-   -   An exemplary TBA surgical kit may consist of (a) a custom        surgical stent 110 for each arch as required, (b) at least one        ablation probe tip 108, 148 labeled its respective surgical        site, (c) at least one tissue trocar 146 (if necessary), and (d)        pre-determined settings 105 for each TBA site along with patient        and operator identification.    -   If feedback controls are a part of the ablation probe tip        design, then the correct in situ tissue temperature settings are        preferably computed and supplied with the ablation probe tips        108, 148 as part of the surgical kit.    -   The generator 104 and/or the hand pieces 106 are standard        equipment in a dental office and/or can be purchased separately.    -   The ablation probe tips 108, 148 may be pre-purchased (or extras        may be kept in a practitioner's office) in which case the TBA        surgical kit would provide a part number or other identifying        information so that the practitioner would know which ablation        probe tip 108, 148 should be used with each guide 112.    -   It should be noted some of the components may not be part of the        physical TBA surgical kit. For example the pre-determined        settings 105 may be provided electronically.

The TBA Procedure 70

Using the TBA procedure 70 described herein, the effective center ofablation 130 a of the ablation probe tip 108, 148 can be positioned at apre-defined angle (ϕ) and pre-defined depth (x) so that the ablationprobe tip's effective center of ablation 130 a is positionedsubstantially in the “middle” of the tooth bud 130 b withinapproximately 50%, 25%, or even less than 10% of the average diameter ofthe tooth bud 120. This is extremely accurate as compared to previousprocedures.

FIG. 4 shows the steps and/or phases in an exemplary preferred TBAprocedure 70: (1) routine screening and diagnosis 72; (2) pre-surgicalscanning 82 (including taking impressions 84 and using scanningtechnology 86); (3) assembling a TBA surgical kit 88 (includingpre-determined settings 105 and a stent 110); (4) operator delivery ofthe surgical phase 90 of the TBA procedure 70 (shown in more detail inFIG. 11); and (5) post-surgical steps (follow-up) 98. Steps (2) and (3)are also referred to jointly as the pre-surgical phase 80 during whichsteps are taken to create (including calculating, manufacturing,fabricating, selecting, and/or assembling) components of the TBA system100 and/or the TBA surgical kit to be provided to the operator. Step (4)is also referred to as the surgical phase 90 of the TBA procedure 70during which the steps shown in FIG. 11 are taken to ablate tooth buds120.

(1) Screening Phase 72

Routine screening using panographic or intra-oral X-ray imagingtechniques is necessary to identify the presence of forming tooth buds120 starting at age 6 through age 12 because of the wide range of agesinvolved with the formation of third molar tooth buds 120.

(2) Impressions and Scanning of Pre-Surgical Phase 80

Once third molar tooth buds 120 have been identified to be present usingstandard screening methods (screening phase 72), the next step is topre-operatively measure the precise three-dimensional location andvolume of each third molar tooth bud 120. As will be discussed, thepre-surgical phase 80, includes both impressions and scanning. Theimpressions 84 may be physical impressions, digital (virtual)impressions, and/or any other impressions known or yet to be discovered.The scanning technology 86 used may be may be any of the scanningtechnology discussed herein and/or any scanning technology known or yetto be discovered. Further, multiple types of technologies may be used incombination.

One practical way to accomplish the pre-operative measurement of theprecise three-dimensional location and volume of each third molar toothbud 120 is to use scanning technology 86 (e.g. computed tomographyvolume scanning such as dental cone beam computed tomography (CBCT)).Scanning technology 86 can be used to accurately generate the necessarythree-dimensional volume scans (computed tomography volume scans) andmeasurements±0.2 mm using, for example, the distal side of erupted firstmolars as durable physical landmarks (although it is possible to usesoft tissue over bone as landmarks). The scanning technology 86 producestooth bud size and position data 86′ (also referred to as “volume scans”and/or “measurements”) that is provided for the step of producing theTBA surgical kit 88. The tooth bud size and position data 86′ may beprovided as a scanning technology file that can be any data filegenerated by the scanning technology 86 with the data necessary tomanufacture or fabricate a stent 110. One exemplary type of scanningtechnology file is a three-dimensional computer aided design (CAD) file.

To accomplish the pre-operative measurement, an impression 84 (that canalso be used for making a model for creating the stent 110) is used. Aphysical impression 84 of the patient's teeth and gum tissue (gingivaltissue 122) is made using traditional or standard impression materialssuch as polyvinyl siloxane (PVS)-type or alginate-type impressionmaterial (although other impression materials can be used) that use achemical-basis for physically obtaining a dental impression of apatient. The impressions 84 are then processed and/or scanned usingscanning technology (e.g. CBCT imaging by dentists and/or CT imaging inthe laboratory), and the resulting volume scan of the impression isemailed (or otherwise transmitted or delivered) to a laboratory and/orfactory where the volume scan is used for manufacturing or fabricating.It is still possible to physically mail the PVS dental impressions 84 tothe designated laboratory and/or factory for manufacturing orfabricating.

Although the scanning technology is discussed primarily in terms ofcomputed tomography volume scanning (e.g. cone beam computed tomography(CBCT) technology), alternative scanning technologies including, but notlimited to, ultrasound scanning technologies and future developedscanning technologies are included in the scope of the invention.Specialty software or programs may be used with the scanning technology86 to accomplish the purpose described herein. It should be noted thatalternative scanning technology 86 (including future developed scanningtechnology) may be used if it is able to accurately generate thenecessary three-dimensional volume scans and measurements+0.2 mm usingthe distal side of erupted first molars (or other landmarks) as durablephysical landmarks. It should be noted that alternative scanningtechnology (including future developed scanning technology) may also beused as long as two- or three-dimensional scanning results in thepositioning of the effective center of ablation 130 a withinapproximately 50%, 25%, or even less than 10% of the average diameter ofthe tooth bud 120.

At this pre-surgical phase 80, scanning may be performed for the purposeof obtaining “digital” impressions instead of traditional physicalimpressions. In other words, for purposes of this disclosure, digitalimpressions 84 should be considered to be an alternative to physicalimpressions 84 and the term “impressions,” unless modified by “digital”or “physical” (or variations thereof) should be considered to includeboth digital and/or physical impressions. Digital impressions do notnecessarily use actual impression material, but instead scan the oralsurfaces—including hard tooth structures and soft tissues such as gumtissue and the mucosal tissue overlying the immediate structure of thetooth bud. Digital impressions (like physical impressions) may be usedto fabricate a physical and/or virtual surgical guide or stent. Usingdigital impressions has exemplary advantages such as improving accuracyand/or eliminating the need to physically mail (or post) the physicaldental impressions.

Digital impressions may be taken using digital imaging systems such as“confocal” imaging systems (e.g. iOC and iTero intra-oral imagingsystems), three-dimensional surface imaging (e.g. 3M's True Definitionunit), and other digital imaging systems known and yet to be discovered.U.S. Pat. No. 7,787,132 to Korner et al., U.S. Pat. No. 7,819,591 toRohaly et al., U.S. Pat. No. 7,990,548 to Babayoff et al., U.S. Pat. No.8,310,683 to Babayoff et al., and U.S. Pat. No. 8,363,228 to Babayoff etal. disclose exemplary imaging systems or technology related to imagingsystems that may be used in this impressions and scanning of thepre-surgical phase 80. These references are hereby incorporated byreference in their entirety. For purposes of this disclosure, thesesystems may be considered to be part of the scanning technology 86.These systems may be used instead of or in conjunction with thepreviously discussed scanning technology (e.g. the CBCT technology).

Using digital imaging systems to take digital impressions may includeusing a digital “wand” that is inserted into the patient's mouth and thesurfaces directly scanned. Alternatively, digital imaging systems may beused to take digital impressions 84 using conventional plasterimpressions (plaster models) that are digitally scanned. Dedicatedlaboratory scanning systems to scan plaster models use yet othertechnologies such as video or laser-based scanning.

(3) Assembling a TBA Surgical Kit 88

The pre-surgical phase 80 of the TBA procedure 70 includes assembling aTBA surgical kit 88. This step of assembling a TBA surgical kit 88preferably includes computing pre-determined settings 105 andmanufacturing or fabricating the stent 110 based on tooth bud size andposition data 86′ obtained from the scanning technology 86. The processof computing pre-determined settings 105 may be controlled by a process(that may be implemented by software or a program). The process ofmanufacturing or fabricating the stent 110 may also be controlled by aprocess (that may be implemented by software or a program).

After the impressions 84 are processed and/or scanned and the tooth budsize and position data 86′ is obtained, the process of manufacturing orfabricating the stent 110 may be carried out using direct-digitalmanufacturing or fabricating techniques similar to the processes usedfor manufacturing or fabricating implant surgical stents directly fromCBCT scans (e.g. the processes used for fabricating SurgiGuide™ andother implant surgical guides) and the process used for manufacturing orfabricating orthodontic aligners (e.g. orthodontic aligners made byAlign Technology or ClearCorrect). The direct-digital manufacturing orfabricating techniques, however, use the tooth bud size and positiondata 86′ to position and angle the surgical guides 112 on the distalaspects of the surgical stents 110 and use the erupted first molars asthe primary landmark for positioning. Although manufacturing orfabricating will usually be done remotely in a laboratory and/orfactory, it is possible that larger clinics will have the ability tomanufacture or fabricate surgical stents 110 in their own in-houselaboratory and/or factory.

Direct-digital manufacturing or fabricating techniques can be defined asany manufacturing or fabricating process that creates physical partsdirectly from data (e.g. three-dimensional CAD files) usingmanufacturing or fabricating techniques including, but not limited to,surgical stent manufacturing or fabricating technologies, rapidturn-around fabrication technologies, computer aided manufacturing(CAM), technologies using computer aided design (CAD), computernumerical control (CNC) milling, “additive” manufacturing,direct-digital laser stereolithography fabrication, “three-dimensionalprinting,” or any other manufacturing or fabricating means known or yetto be discovered that is capable of using the results generated byscanning to manufacture or fabricate the custom surgical stents. Becauseof the possibility for the integrated use of direct-digital volumescanning of impressions, low manufacturing costs, and rapid turn aroundtimes, use of direct-digital manufacturing or fabricating techniques isone preferred manufacturing or fabricating technique, but moretraditional manufacturing or fabricating techniques that require morelabor intensive manual laboratory processing could also be used.

At least one process that may be implemented as software or as at leastone program (e.g. custom software enhancements in the CBCT software)will preferably assist in the direct-digital manufacturing orfabricating of the surgical stents 110 and define (and/or compute orcalculate) the pre-determined settings 105. This process would includedefining (and/or computing or calculating) positioning and entry angledata required for placement of the ablation probe tip's effective centerof ablation 130 a into the middle of the targeted tooth bud 120.Additionally, tooth bud volumes are preferably computed (possibly usingthe scanning technology) and then the tooth bud volumes are used todetermine the pre-determined settings 105 necessary to effecttherapeutic ablation. Tooth bud volumes will generally range from 4.0 mmto 12.0 mm in diameter at ages 6-12. The ablation means 104′ andtreatment times are preferably considered in the calculations. Companiesthat make CBCT imaging equipment promote the development ofprocedure-specific software in order to gain end-user acceptance oftheir imaging systems in the market place. The process may usecalculations and/or look-up charts (e.g. based on experimental data) fordetermining the necessary settings.

FIG. 12 is a flowchart showing the steps of a process (that may beimplemented as one or more software programs or subprograms if the shownsteps are divided) for manufacturing or fabricating custom surgicalstents 110 and/or determining the pre-determined parameter settings 105a and/or treatment time settings 105 b. As shown, the process beginswith receiving pre-operative measurements of the precisethree-dimensional location and volume of each third molar tooth bud andinformation regarding the ablation probe unit including its ablationmeans capabilities 200. To make the stents 110, the process wouldpreferably include the following steps: determining an entry point foran ablation probe tip 210; computing the angle and depth of the path(including the three-dimensional path of insertion) between the entrypoint and the middle of a tooth bud 212; taking into consideration thedepth of the path, creating or selecting an ablation probe tip havingthe proper distance between its mechanical stop and its center ofablation so that the ablation probe tip will be inserted so that itscenter of ablation will be in the middle of the tooth bud 214; takinginto consideration the angle and depth of the path and the thickness ofthe surgical stent, computing the surgical guide pathway (including thethree-dimensional path of insertion) through which the ablation probetip will be inserted so that its center of ablation will be in themiddle of the tooth bud 216; and providing the surgical guide pathway asoutput for the creation of a surgical stent with surgical guides 218. Tocalculate the pre-determined parameter settings 105 a and/or treatmenttime settings 105 b, the process would preferably include the followingsteps: taking into consideration the information regarding the ablationprobe unit including its ablation means capabilities, determining theproper power settings 220; taking into consideration the informationregarding the ablation probe unit including its ablation meanscapabilities, determining the proper time settings 222; and providingthe proper power and time settings as output for use in programming theablation probe unit or generator 224.

As described above, in addition to the surgical stent(s) 110 and thepre-determined settings 105, the TBA surgical kit may include at leastone ablation probe tip 108, 148 labeled for its respective surgicalsite, at least one tissue trocar 146 (if necessary), and patient andoperator identification.

The TBA surgical kit is provided to the operator.

(4) Surgical Phase 90

FIGS. 6-10 show graphically, and FIG. 11 shows as a flow chart, thesurgical phase 90 of the TBA procedure. The surgical phase 90 may beperformed by a dental operator (dental practitioner) in his office (e.g.a pediatric and/or general dental office) under normal officeconditions. At this point, the generator 104 has been programmed withthe pre-determined settings 105 and normal surgical procedures have beenfollowed. The generator 104 is preferably tuned so that the ablationmeans 104′ is set to ablate the small, substantially spherical ablationvolumes of third molar tooth buds 120 in order to minimize (or possiblyeliminate) collateral osseous and soft tissue damage, especially damageto adjacent second molars that are likely not yet erupted. Further, thesurgical phase 90 uses single-use and disposable delivery systems thatuse components designed for intra-oral use.

Summarily, as shown in FIG. 11, the first step is physically seating asurgical stent 160 in a patient's mouth. Next, the operator makes anaccess path at the at least one tooth bud surgical site 162. Theoperator also places the ablation probe tip so that the center ofablation is in the middle of a tooth bud at the at least one tooth budsurgical site (using the custom surgical stent to guide the placement)164. It should be noted that if the ablation probe tip is“self-introducing,” the step of making an access path and the step ofplacing the ablation probe tip may occur simultaneously. Then, the atleast one tooth bud is at least partially ablated 166 and the ablationprobe tip is removed from the tooth bud 168. These and other exemplarysteps are detailed in the following paragraphs.

The operator preferably starts the surgical phase 90 by placing thesurgical stent 110 into place onto the patient's teeth prior toadministering local anesthetic to the surgical site. The localanesthetic will then be administered through the surgical stent 110 andguides 112 that are in close approximation with the gingival tissue 122,thus reducing the amount of anesthetic necessary because of the preciseplacement of anesthetic agent. Achieving local anesthesia in thisprocedure will be easier than anesthetizing lower permanent molar teethfor routine fillings since only soft tissues, which will be 8.0 mm to15.0 mm deep, are involved.

The step of physically seating a surgical stent 110 may also includephysically seating the surgical stent in a patient's mouth, physicallyseating the surgical stent on a patient's erupted teeth, physicallyseating the surgical stent on at least one tooth in a patient's mouth,physically seating the surgical stent on a patient's soft tissue,physically seating the surgical stent on a patient's bone, or acombination of the above steps (e.g. physically seating the surgicalstent on a patient's teeth, soft tissue, and bone).

Once the custom surgical stent 110 is in place and the patient is fullyanesthetized, the operator then mechanically gains access to the toothbud 120 through the stent surgical guides 112 by creating (introducing)a small surgical access path opening through the gingival tissue 122approximately 0.1 mm to 2.0 mm (and more particularly 0.5 mm to 1.0 mm)in diameter using tissue trocars. If the ablation probe tips 108, 148are designed to be strong enough and sharp enough to act as“self-introducing” probe tips, they can be used to introduce thesurgical access path. On the other hand, if the ablation probe tipitself is not self-introducing, the surgical access path may beintroduced using known techniques then there will be no need forseparate tissue trocar 146.

It should be noted that the surgical access path is preferably anincision, a puncture, or a hole through the gingival tissue 122. If aself-introducing probe tip is used, the surgical access path hassubstantially the same diameter as the ablation probe tip 108, 148. Ifthe probe tip is not self-introducing, the surgical access path may be asutureless puncture (0.1 mm to 2.0 mm in diameter) or, moreparticularly, a sutureless puncture (0.5 mm to 1.0 mm in diameter).Alternatively, a trocar “punch” may be made through tough gingivaltissue 122. Regardless of the procedure used to introduce the surgicalaccess path, using a surgical access path to gain access or allowplacement of the ablation probe tips 108, 148 to the tooth bud 120 doesnot kill, damage, or otherwise cause necrosis to the surrounding softtissues (e.g. gingival tissues 122). This can be compared to otherprocesses such as coring, boring, cutting, electrosurge ablating, orother invasive procedures that kill, damage, and/or otherwise causenecrosis to the soft tissue to which the invasive procedure has beenapplied. Although the preferred procedures for introducing the surgicalaccess path might kill individual cells, the soft tissue (the gingivaltissue 122) does not become necrosed because the tissue is a collectionof cells that can heal itself.

As shown in FIGS. 6 and 7, the next step in the surgical phase 90 is toinsert the designated ablation probe tip 108, 148 through the surgicalstent 110 and into the tooth bud space until it is mechanically“stopped” in order to position the probe to the prescribed depth (whichwould be the pre-defined depth). The surgical stent 110 and/or itssurgical guides 112 are used to control the angle (ϕ) and/or depth (x)of the ablation probe tip 108, 148 so that the effective center ofablation 130 a of the ablation probe tip is in the middle of the toothbud 130 b. It should be noted that the effective center of ablation 130a for any given ablation technology does not necessarily correspond withthe tip of the ablation probe. For instance, microwave ablation probeshave windows or slots that may be 0.5 mm to 2.0 mm from the tipdepending on the frequency of the wavelength used. Cryoablation probeshave their center of ablation roughly in the middle of the probe,depending on the design and refrigerant used. A mechanical stopstructure 140 on the ablation probe tip 108 preferably seats firmly ontothe mechanical stop structure 142 of the surgical stent guide 112 toprevent over extension of the ablation probe tip 108. Alternatively, themechanical stop structure 150 on the ablation probe tip 148 may be usedto prevent over extension of the ablation probe tip 108.

FIG. 8 shows embedded temperature sensors 144 (or other types offeedback control mechanisms) that may be used during the ablationprocess. An independent feedback process using the temperature sensors144 is preferable for this clinical procedure. Use of temperaturesensors 144 along with monitoring probe impedance characteristics andpercentage of reflected energy in RF/MW circuits will provide “go/no go”output for the clinician. Control algorithms are preferably used toaccelerate initial ablation means 104′ input followed by lower-leveltemperature maintenance for a defined period of time with independentconfirmation that results in a fast process while simultaneouslyassuring complete tooth bud ablation.

FIG. 9 shows the actual ablation process. Activation of the ablationprobe unit 102 to perform the ablation process is executed according tothe pre-determined settings 105. Activation of the ablation probe unit102 causes the generator 104 to provide the ablation means 104′ thatpasses through the hand piece 106 and the ablation probe tip 108, 148and into the tooth bud 120. This step of at least partially ablating thetooth bud is preferably accomplished without ablating any surroundinggingival tissue (although a minimal amount of surrounding gingivaltissue may be ablated as an accidental byproduct of the step). This canalso be thought of as the activation of the ablation probe unit 102creating a zone of ablation that resides predominantly or completelywithin the tooth bud 120. The temperature sensors 144 (feedback controlmechanisms) assure successful delivery of adequate ablation means 104′to ablate the tooth bud 120 while minimizing damage to adjacent osseousand soft tissues by, for example, eliminating over-heating. Given thesmall tissue volumes involved for pediatric patients, activation usingan RF ablation means 104′ would have an ablation time that is preferablyless than three (3) minutes and activation using an MW ablation means104′ would have an ablation time that is preferably less than thirty(30) seconds.

FIGS. 10 and 34 show the ablation probe tips 108, 148 being removed fromthe now ablated tooth bud 120′. As shown in these figures, any accesspath created by the procedure rapidly closes.

(5) Post-Surgical Phase 98:

After the surgical phase 90, the patient may have follow-up including,but not limited to, post-surgical instructions and, if necessaryfollow-up care and screening.

Post-surgical instructions that may be given to parents include thefollowing: kids can go out and play immediately unless they weresedated, no post-surgical pain medication is necessary, bleeding (ifany) will be gone in minutes, and post-surgical X-ray screening may benecessary at patient's next routine 6-month hygiene cleaning appointmentto verify full ablation.

Simulated TBA Procedure 70

The following paragraphs, along with FIGS. 13-29, detail an exemplarysimulated TBA procedure 70 including routine screening and diagnosis 72,the pre-surgical phase 80, and the surgical phase 90. (The structure ofFIGS. 30-34 would be used in a similar manner making adjustments assuggested herein.) In several of these figures, a patient's mouth 124(with gums 122 and teeth 126) is shown that looks like a stone model,but it should be understood that unless otherwise specified the shownmouth 124 would be a live patient's mouth.

As shown in FIG. 4, the TBA procedure begins with routine screening anddiagnosis 72. FIG. 13 is a panographic X-ray showing a patient whosethird molar tooth buds 120 in the #17 & #32 positions are treatable by aTBA procedure 70. FIG. 14 is a pre-operative cone beam computedtomography (“CBCT”) scan (although other types of volume scanning couldbe used) of a patient. In a real procedure, the volume scan would betaken of the specific patient on which the TBA procedure 70 is beingperformed. This CBCT “reconstructed” panographic scan has a 1.0 mm scalealong its bottom edge. FIG. 15 is a series of CBCT volume scancross-sections showing successive 1.0 mm slices through both #17 and #32in 1.0 mm increments. Each X-ray corresponds to 1.0 mm locations alongthe scale of FIG. 14. The left-side scale is 1.0 mm vertically. Themaximum tooth bud diameters are measured to be 8.0-9.0 mm.

For purposes of describing this exemplary simulated TBA procedure 70,the use of a physical impression 84 is described in connection withFIGS. 16-19. It should be noted that an alternative exemplary TBAprocedure 70 could use a virtual impression 84.

FIG. 16 shows a pre-operative physical upper-arch impression 84 beingtaken of the simulated patient's mouth 124 (shown as a stone model forclarity, but an impression 84 would be taken of the patient himself)using an impression tray 128. It is assumed that all four tooth buds ofthe wisdom teeth are present in the simulated patient. FIG. 17 is across-sectional view of the physical upper-arch impression 84 beingtaken of a simulated patient. FIG. 18 shows the completed physicalupper-arch impression 84. A similar process would be performed tomanufacture or fabricate a pre-operative physical lower-arch impression84. At this time the practitioner may send impressions 84 and volumescan data to a laboratory and/or factory for processing.

The laboratory and/or factory uses the physical impressions 84 (althoughdigital impressions 84 could be used) and volume scan data (scanningtechnology file) to create (including calculating, manufacturing,fabricating, selecting, and/or assembling) components of the TBA system100 (including the surgical stents 110 and the pre-determined settings105). The surgical stents 110 and the pre-determined settings 105 andother components are then assembled into the TBA surgical kit to beprovided to the operator.

FIG. 19 shows the completed physical upper-arch impression 84, alongwith a stone model 85 that will serve as a “positive” for manufacturingor fabricating a surgical stent 110 for that patient's upper-arch.Alternatively, when using stereolithography manufacturing to manufactureor fabricate surgical stents 110, the physical impressions 84 can becomputed tomography (“CT”) scanned to digitize as an alternative tomaking physical intermediates. The CT volume scan file (scanningtechnology file) can then be emailed (or otherwise directly transmitted)for direct manufacturing or fabricating. Alternatively, the practitionermay handle the processing “in house.”

FIG. 20 is a CBCT scan with notations showing the measurement of theperpendicular angle of entry into the tooth bud 120. The measurement isbased on the distal aspect of the molar and the occlusal bite plane ofthe teeth. FIG. 21 is a series of X-rays with notations showing themeasurement of the lateral angle of entry. The measurement is determinedrelative to the vertical axis in order to avoid the jaw's boneyinterferences during surgical placement of the ablation probe unit 102.FIG. 22 is a CBCT scan with highlights showing the computed volume ofeach tooth bud 120. CBCT volume data is used to determine and/orcalculate the pre-determined settings 105.

FIG. 23 shows the resulting surgical stent 110 that will be placed in apatient's mouth 124. The shown stent has two surgical guides 112 basedupon the location of the patient's two tooth buds to be ablated.

The surgical stent(s) 110 and the pre-determined setting(s) 105 areprovided to the operator along with the rest of the TBA surgical kit.

Prior to the surgical phase 90 of the TBA procedure 70, the ablationprobe unit 102 and/or the generator 104 should be set up so that atleast one pre-determined setting 105 is correctly entered for at leastone tooth bud 120 with safety interlocks carefully considered. (Thepre-determined settings 105 may all be entered prior to the surgicalphase 90 or they may be entered one at a time.) The surgical phase 90 ofthe TBA procedure 70 may then be performed.

FIG. 24 shows topical anesthetic 87 being applied to the base of thesurgical guide 112 (FIG. 24) prior to the surgical stents 110 beingseated in a patient's mouth 124.

FIG. 25 shows the surgical stent 110 being seated on the upper-arch ofthe simulated patient's mouth 124 (shown as a stone model for clarity).This process would be repeated on the lower arch of the simulatedpatient.

FIG. 26 shows a local anesthetic being injected 89 into each sitethrough a surgical guide 112 of the stent 110.

FIG. 27 shows a tissue trocar 146 being used to create an access paththrough the gingival tissue 122 to the base of each tooth bud 120. Thetissue trocar 146 is only necessary if self-introducing ablation probetips 108 are not used.

FIG. 28 shows an ablation probe tip 108 with mechanical stop structure140′ (shown as a shoulder) being inserted through the surgical guide112. This would be similar to the position of the ablation probe tip 108in FIG. 6. (Alternatively, if the alternative ablation probe tip 148with mechanical stop structure 150 was inserted through the surgicalguide 112, the position would be similar to the position of thealternative ablation probe tip 148 in FIG. 30.)

FIG. 29 shows the ablation probe tip 108 positioned through the surgicalguide 112 and into the tooth bud 120 through the surgical guide 112 sothat the ablation probe tip's effective center of ablation 130 a is inthe middle of each tooth bud 120. This would be similar to the positionof the ablation probe tip 108 in FIG. 7. (Alternatively, if thealternative ablation probe tip 148 was used, the position would besimilar to the position of the alternative ablation probe tip 148 inFIG. 31.)

The ablation means 104′ is delivered in this position (FIG. 9, or FIG.33 for the alternative ablation probe tip 148). The ablation means 104′is delivered based on the pre-determined settings 105 (e.g. times,intensities, and other prescribed settings unique to each tooth bud).

The ablation probe tip 108 would then be removed and the processrepeated at the site of each tooth bud 120. Once the entire surgicalphase 90 is complete, the surgical stents 110 are removed.

Finally, the dental practitioner or an assistant provides post-surgicalinstructions to the patient or a caregiver of the patient.

Alternative Scanning and Fabrication of Custom TBA Surgical Kits

An alternative to the pre-surgical phase 80 of the TBA procedure 70described above includes simultaneous three-dimensional scanning of bothhard tissues (bone and teeth) and soft tissues (tooth bud 120 andgingival tissue 122). From the information obtained using this uniquesimultaneous three-dimensional scanning, a custom surgical stent 110 maybe manufactured or fabricated. As discussed, the custom surgical stent110 is used in the surgical phase 90 to help with the placement of thecenter of ablation 130 a into a tooth bud 120 that results in toothagenesis.

The simultaneous three-dimensional scanning uses a single scan to obtainboth soft tissue and hard tissue information. Soft tissue informationgenerally does not show on a scan, although progress in volume scanningis improving and this may be possible in the near future. Known andfuture technologies able to provide a scan image of soft tissue areincluded in the scope of this invention. A typical X-ray scan will onlyshow the hard tissue. One way to obtain both soft and hard tissueinformation using simultaneous three-dimensional scanning, a physicaldental impression 84 is used that can be viewed on an X-ray. Thephysical dental impression 84 is made of materials that are preferably“contrast optimized” for high resolution X-ray volume scanning. Theideal level of contrast agent in the range of 25% to 75% radiopacity(such as barium or iodine based compounds) is mixed into the dentalimpression materials so that the highest level of surface detail can bepicked upon when volume scanning the physical dental impression 84. Thephysical dental impression 84 is placed in the patient's mouth 124during the X-ray volume scan. The resulting X-ray volume scan imagewould show the tooth distinguished (is visible) and the physical dentalimpression 84 distinguished (is visible) and the void therebetween wouldbe the soft tissue and would therefore be “visible.” The resulting X-rayvolume scan with both hard and soft tissue information may then be usedto formulate the custom stent 110 used in the surgical phase 90described herein. In other words, an X-ray volume scan image isgenerated in which hard tissue (e.g. a tooth) is visible hard tissue andthe physical dental impression 84 is a visible dental impression andsoft tissue (e.g. gingival tissue 122) is “visible” as the space betweenthe visible hard tissue and the visible dental impression.

One separate preferred pre-surgical phase 80 of the TBA procedure 70preferably includes using X-ray volume scans of physical or digitaldental impressions 84 to manufacture or fabricate surgical stents 110.The X-ray volume scan of the dental impression 84 is “super imposed”over the patient X-ray volume scan (e.g. CBCT scanning) using the dentalhard tissues (the teeth) to “snap” the two volume scans together into anaccurate overlay so that soft tissues of the mouth (which cannot beX-ray volume scanned or otherwise obtained directly) are accuratelydefined for the surgical stent manufacturing or fabricating (which musttake into account the soft tissue and teeth) and probe positioning(which must take into account the tooth bud positioning from thepatient's CBCT scan).

One separate preferred pre-surgical phase 80 of the TBA procedure 70preferably includes using physical dental impression materials that are“contrast optimized” for high resolution X-ray volume scanning that isthen used to manufacture or fabricate surgical stents 110. The ideallevel of contrast agent (such as barium or iodine based compounds) ismixed into the physical dental impression materials so that the highestlevel of surface detail can be picked up on when CT volume scanning thephysical dental impression 84.

Virtual Stent System

The at least one custom surgical stent 110 (a physical stent system orphysical stent) could be replaced (or used in conjunction with) avirtual stent system (also referred to as a “virtual stent”) in a TBAprocedure or with a TBA system. As set forth in the Background, U.S.Pat. No. 8,221,121 to Berckmans, III et al., U.S. Pat. No. 8,013,853 toDouglas, et al., U.S. Pat. No. 7,812,815 to Banerjee, et al., U.S. Pat.No. 7,457,443 to Persky, U.S. Pat. No. 7,249,952 to Ranta, et al., U.S.Pat. No. 5,688,118 to Hayka et al., U.S. Patent Publication No.20100316974 to Yau, et al., U.S. Patent Publication No. 20100311028 toBell, et al., and U.S. Patent Publication No. 20090253095 to Salcedo, etal. are references that address aspects of virtual dentistry. Thesereferences are hereby incorporated by reference in their entirety.Although none of these references are used in a TBA procedure or with aTBA system, many of the details of the virtual stent system may beimplemented using aspects described in these references.

As a broad concept, a virtual stent system uses the three-dimensionalvolume scans (computed tomography volume scans) created using scanningtechnologies (e.g. computed tomography volume scanning such as cone beamcomputed tomography (CBCT) scanning and MRI volume scanning) displayedon a display system (e.g. a computer screen). The three-dimensionalvolume scans are taken of a specific patient on which the TBA procedureis being performed. Calculations are made to determine or calculate theparameter settings, the treatment time settings, the pre-defined angle(ϕ), and/or the pre-defined depth (x). The calculations of thepre-defined angle (ϕ) and pre-defined depth (x) are used to define athree-dimensional path of insertion through which the ablation probe tip108, 148 accesses the gingival tissue 122 and the tooth bud 120 so thatthe center of ablation 130 a substantially coincides with or overlapsthe middle of the tooth bud 130 b. Using sensors 230 on the ablationprobe tip 232 and/or the hand piece 106 to transmit movement, areal-time representation of the ablation probe tip 232 and/or the handpiece 106 is overlaid on the displayed three-dimensional volume scans.Movement of the ablation probe tip 232 is displayed in real-time. (Itshould be noted that the sensors 230 may be the ablation probe tipitself, the hand piece itself, sensors such as those described in thereferences incorporated herein, and any known or yet to be discoveredsensors that are sensible from within a patient's mouth and are safe foruse in a patient's mouth. It should also be noted that the sensors 230have associated sensing technology (not shown) for sensing the sensors230 and communicating and/or interpreting the position of the ablationprobe tip 232 and/or the hand piece 106 so that a representation of theablation probe tip 232 and/or the hand piece 106 is displayed on thedisplay 240. This sensing technology may be any known or yet to bediscovered sensing technology capable of sensing the sensors within apatient's mouth (and is safe to use for such a purpose) includingsensing technology described in the references incorporated herein.) Theoperator is able to monitor in real time the relationship of theeffective center of ablation 130 a of the ablation probe tip 232 ascompared to the middle of the tooth bud 130 b.

FIG. 35 shows a horizontal hand piece 234 and ablation probe tip 232with sensors 230 and a display 240 with a representation of thehorizontal hand piece 234 and ablation probe tip 232 displayed thereon.FIG. 36 shows a vertical hand piece 234 and ablation probe tip 232 withsensors 230 and a display 240 with a representation of the vertical handpiece 234 and ablation probe tip 232 displayed thereon. The sensors 230would pick up movement of the hand piece 234 and ablation probe tip 232in real time and would display the movement of the sensored hand piece234 and sensored ablation probe tip 232 as real-time representations ofthe hand piece 234 and ablation probe tip 232 on the display 240.

FIGS. 37 and 38 show an exemplary patient X-ray volume scan shown on adisplay 240 with a representation of the hand piece 234 and/or ablationprobe tip 232 displayed as well as exemplary indicators of position(position indicator 250) and status (status indicator 252) shown on thedisplay 240 in real time. FIG. 37 shows the sensored ablation probe tip232 just barely inserted into the tooth bud such that the center ofablation 130 a is relatively far from the middle of the tooth bud 130 b.The position indicator 250, therefore, would show a large percentage(shown as 98% which is the percentage of the average diameter of thetooth bud at which the center of ablation 130 a is located in thisposition). The status indicator 252 is shown as “inactive” because thesystem would not be activated (it is not delivering ablation means 104′)so far from the middle of the tooth bud 130 b. FIG. 38 shows theablation probe tip 232 in a relatively optimal position for ablationwithin the tooth bud. In other words, the center of ablation 130 a isrelatively close to the middle of the tooth bud 130 b. The positionindicator 250, therefore, would show a small percentage (shown as 8%which is the percentage of the average diameter of the tooth bud atwhich the center of ablation 130 a is located in this position). Thestatus indicator 252 is shown as “active” because the system might beactivated (delivering ablation means 104′) this close to the middle ofthe tooth bud 130 b.

FIG. 39 is an enlarged view of the display 240 showing virtual surgicalguide angle markings 260, a virtual stop marking 262, and virtual targetmarkings 264. The virtual surgical guide angle markings 260 are based onthe three-dimensional path of insertion (defined by the pre-definedangle (ϕ) and pre-defined depth (x)). Although these markings may beshown using an enlarging setting for the display 240, they may also bepresent on the regular (non-enlarged) display 240. In preferredembodiments, the system would not be able to be activated if the centerof ablation 130 a was not in proper relationship to the middle of thetooth bud 130 b.

The virtual surgical guide angle markings 260 function in a mannersimilar to the physical surgical guide 112 (providing angle guidance) asthey show the representation of the ablation probe tip 232 in the properpre-defined angle (ϕ) in which the operator can guide the ablation probetip 232 so that its center of ablation 130 a is placed into the middleof the tooth bud 130 b. The guide angle markings 260 show the properpath so that the user would see the representation of the ablation probetip 232 outside the path if the sensored ablation probe tip 232 is noton the proper path. Preferably the representation is three-dimensionalso that the operator would see a three-dimensional representation of theablation probe tip 232 and a three-dimensional representation of thepath of insertion. Further, the operator may be alerted that thesensored ablation probe tip 232 is not at the proper pre-defined angleusing, for example, visual indicators (e.g. two-dimensional orthree-dimensional graphical representations, lights on the display 240,warning messages on the display 240, or lights on the hand piece 234 orablation probe tip 232), audible indicators (e.g. buzzing or an audiblewarning message), tactile indicators (e.g. the vibrating of the handpiece 234), or a combination thereof.

At least one virtual stop marking 262 is displayable on the display 240to provide stop information to limit the depth of said sensored ablationprobe tip 232 to a pre-defined depth (x). The virtual stop marking 262functions in a manner similar to the physical stops 140, 150 (whichwould not technically be needed for the sensored ablation probe tip 232)as the virtual stop marking 262 limits (or at least provides a visualindication of the proper limit for) the representation of the ablationprobe tip 232 so that its center of ablation 130 a is at the properpre-defined depth (x) to be placed into the middle of the tooth bud 130b. The operator may be alerted that the center of ablation 130 a is notat the proper pre-defined depth (x) using, for example, visualindicators (e.g. lights on the display 240, warning messages on thedisplay 240, or lights on the hand piece 234 or ablation probe tip 232),audible indicators (e.g. buzzing or an audible warning message), tactileindicators (e.g. the vibrating of the hand piece 234), or a combinationthereof. It should be noted that the virtual stop marking 262 may not beat the middle of the tooth bud 130 b. The virtual stop marking 262 wouldtake into consideration the ablation probe tip 232 and its center ofablation 130 a and indicate the proper position for the ablation probetip 232 such that its center of ablation 130 a (which may not be at itsultimate tip) is positioned at the middle of the tooth bud 130 b. Thevirtual stop marking 262 and/or the alerts (e.g. visual indicators,audible indicators, tactile indicators, or a combination thereof) are atype of “stop information,” the ablation probe tip 108, 148 being depthlimited to the depth indicated by the stop information (which would bethe depth at which the center of ablation 130 a substantially coincideswith or overlaps with the middle of the tooth bud 130 b).

The virtual target markings 264 are an optional feature (in that theyare not strictly necessary if there are virtual surgical guide anglemarkings 260 and a virtual stop marking 262). Alternatively, the virtualtarget markings 264 could replace one or both of the virtual surgicalguide angle markings 260 and a virtual stop marking 262. The virtualtarget markings 264, however, might represent the “middle” of the toothbud 130 b within, for example, approximately 50%, 25%, and 10% of theaverage diameter of the tooth bud 120. This information could be helpfulto the operator. The operator may be alerted that the ablation probe tip232 is not at the proper position using, for example, visual indicators(e.g. lights on the display 240, warning messages on the display 240, orlights on the hand piece 234 or ablation probe tip 232), audibleindicators (e.g. buzzing or an audible warning message), tactileindicators (e.g. the vibrating of the hand piece 234), or a combinationthereof.

The sensored hand piece 234 and/or ablation probe tip 232 overlapped onthe patient X-ray volume scan on the display 240 and the indicators 250,252 and/or markings 260, 262, 264 thereon are the major components of apreferred implementation of the virtual stent system in a TBA procedureor with the TBA system. Some versions of the virtual TBA system do notinclude any physical stent 110, because the virtual stent system guidesthe sensored hand piece 234 and/or ablation probe tip 232 so that thecenter of ablation 130 a is placed into the middle of the tooth bud 130b.

In a TBA procedure, the virtual stent system may be operated manually,automatically (e.g. computer controlled), or a combination thereof. Thesensored hand piece 234 in an automatic system (or a combination system)may be part of a robotic system that physically manipulates the physicalsensored hand piece 234 and/or ablation probe tip 232. The automaticsystem (or a combination system) may also control the generator 104 asdescribed herein. If the system is being operated manually, the systemacts as a failsafe in that it may automatically control or have overridecontrol of the status (making the system inactive) of the virtual stentsystem such that if the center of ablation 130 a is not in the middle ofthe tooth bud 130 b, the system will not allow ablation or will ceaseablation if the center of ablation 130 a moves out of the middle of thetooth bud 130 b (or if any other problem is sensed). On the other hand,if the system is being operated automatically, the operator acts as afailsafe in that he may manually control or have override control of thestatus (making the system inactive) of the virtual stent system suchthat if the center of ablation 130 a is not in the middle of the toothbud 130 b, the system will not allow ablation or will cease ablation ifthe center of ablation 130 a moves out of the middle of the tooth bud130 b (or if he sees any other problem).

For most of the specific steps set forth below, the operator may watchthe step being performed on the display 240 as he manually (physically)manipulates the sensored ablation probe tip 232 to perform the step. Insuch a case, the system would monitor the progress and alert theoperator if there was a problem (e.g. the ablation probe tip 232 is notat the proper pre-defined angle) using, for example, visual indicators,audible indicators, tactile indicators, or a combination thereof. As setforth, during manual operation the system may automatically override thestatus (making the system inactive) to prevent ablation or furtherablation if there is any problem (e.g. if the center of ablation 130 amoves out of the middle of the tooth bud 130 b). On the other hand, theoperator may monitor the step being performed on the display 240 as theautomatically controlled sensored ablation probe tip 232 performs thestep automatically (e.g. using a robotics system). As set forth, theoperator may manually override the status (making the system inactive)to prevent ablation or further ablation if there is any problem (e.g. ifthe center of ablation 130 a moves out of the middle of the tooth bud130 b).

As shown in FIG. 40, the following steps are exemplary steps in a TBAprocedure using the virtual stent system.

Parameter Setting Step 300: The ablation probe properties (center ofablation, diameter, length, power output properties, etc.) areprogrammed into the virtual guide software along with the patient'sspecific ablation parameters (size of tooth bud, power setting, time toablate, etc). These ablation probe properties are used in steps such asthe guiding step and the ablating step. These properties may be obtainedusing a procedure similar to that shown in FIG. 12 and discussed herein.The major difference between the procedure of FIG. 12 and one used tocalculate the parameters for the TBA procedure using the virtual stentsystem is that the virtual system would not necessarily require theproduction of a physical stent, but would instead need the calculationof the virtual surgical guide angle markings 260, a virtual stop marking262, and/or virtual target markings 264 to be displayed on the display240.

Calibrating Step 302: As set forth above, the sensored hand piece 234and/or ablation probe tip 232 is represented overlapped on the patientX-ray volume scan on the display 240. In a perfect world, this stepwould be optional. In the real world, however, an operator would want toverify that the representation of the sensored hand piece 234 and/orablation probe tip 232 is in the proper position relative to thepatient's mouth. This may be accomplished using visual checks such asthe operator positioning the physical absolute tip of the ablation probetip 232 in relation to a known physical point of the patient's mouth.This may be, for example, an easily recognizable point on one of thepatient's erupted teeth. The operator then confirms that the virtualabsolute tip of the ablation probe tip 232 is in the same relationshipwith the same point of the patient's mouth shown on the patient X-rayvolume scan on the display 240. If these do not match, appropriateadjustments may be made.

Anesthetizing Step 304: The patient is anesthetized using the sensoredablation probe tip 232 or a sensored specialized anesthetic tip (similarto the one shown and discussed in relation to FIG. 26 and having sensorsthereon). The virtual stent system may be used as the visual guide (e.g.virtual surgical guide angle markings 260, a virtual stop marking 262,and/or virtual target markings 264) for separately inserting theanesthetic needle and recommending the placement of the needle in themiddle of the tooth bud. The sensored anesthetic needle may be of aknown length and may be displayed on the display 240 in order to placethe sensored anesthetic needle in the middle of the tooth bud 130 b soas to provide “virtual guided anesthesia” into the tooth bud 120. Whenthe system indicates that the anesthetic needle is properly placed, theanesthetic is administered manually or automatically. The monitoring andoverride safeguards are preferably used in this step, although damagecaused by incorrect placement of the sensored anesthetic needle would berelatively minor.

Introducing Step 306: In this step, the sensored ablation probe tip 232is introduced to the tooth bud 120. The operator may watch the insertionprocess on the display 240 as he physically manipulates the sensoredablation probe tip 232. Alternatively, the operator may monitor theinsertion process on the display 240 as the sensored ablation probe tip232 is inserted automatically (e.g. using a robotics system). Theintroducing step may be implemented as a single step if the sensoredablation probe tip 232 is self-introducing. Alternatively, theintroducing step may be implemented in two steps if the sensoredablation probe tip 232 is not self-introducing. The two steps would gainaccess to the tooth bud 120 through the stent surgical guides 112 bycreating (introducing) a small surgical access path opening through thegingival tissue 122 approximately 0.1 mm to 2.0 mm (and moreparticularly 0.5 mm to 1.0 mm) in diameter using sensored tissue trocarsor other sharp tools. Then, there is the actual step of introducing thenon-self-introducing sensored ablation probe tip 232. The monitoring andoverride safeguards described herein are preferably used in this step.

Guiding Step 308: In this step, the sensored ablation probe tip 232 isguided by the virtual surgical guide angle markings 260 (FIG. 39) andthe virtual stop marking 262 (FIG. 39) to a position in which theeffective center of ablation 130 a of the ablation probe tip is in themiddle of the tooth bud 130 b. The operator may watch the insertionprocess on the display 240 as he physically manipulates the sensoredablation probe tip 232. The virtual target markings 264 (FIG. 39) mayalso provide an indication that the sensored ablation probe tip 232 iswithin approximately 50%, 25%, and 10% of the average diameter of thetooth bud 120. The position indicator 250 (FIGS. 37 and 38) provide evenmore accurate data as to the positioning of the effective center ofablation 130 a of the ablation probe tip relative to the middle of thetooth bud 130 b. If the operator were manually manipulating the sensoredablation probe tip 232, the system would monitor the progress and alertthe operator that the ablation probe tip 232 is not at the properposition using, for example, visual indicators, audible indicators,tactile indicators, or a combination thereof. Alternatively, theoperator may monitor the progress on the display 240 as the sensoredablation probe tip 232 is inserted automatically (e.g. using a roboticssystem). The monitoring and override safeguards described herein arepreferably used in this step.

Readying Step 310: Visual indications on the display 240 (and possiblyaudible or tactile indications) are used to indicate that the effectivecenter of ablation 130 a of the ablation probe tip is properlypositioned relative to the middle of the tooth bud 130 b. Such visualindications may include the position indicator 250 reaching a propernumber (this may be based on pre-determined tolerances that may beprogrammed into the system with the other parameters). Other visualindicators could be color changes, flashing, or text (e.g. “ready toablate”) on the visual display 240. The operator may also have toprovide a “ready input” indicating that he has independently verifiedthe ready condition and is authorizing the ablation.

Ablating Step 312: When both the operator and the system are “ready” theablation may be triggered and ablation means 104′ is delivered throughthe properly positioned ablation probe tip 232 to middle of the toothbud 130 b. The monitoring and override safeguards described herein maybe used and may allow either the system (automatic) or the operator(manual) to cease ablation for any reason. During ablation, a visualindicator (e.g. a countdown reading based upon the programmedparameters) or other indicators preferably provide constant feedback tothe operator about the ablation progress. The system preferably deliversthe correct ablation energy level for the size of the tooth bud byactively measuring the energy being input (a closed loop system) andcontinuously correcting the physical position of the effective center ofablation 130 a of the ablation probe tip relative to the middle of thetooth bud 130 b. The monitoring and override safeguards described hereinare preferably used in this step.

Completing Step 314: Based on constant monitoring and feedbackpertaining to the tooth bud and surrounding tissues, the ablationprocess, the system itself, and/or the pre-determined parameter settingsand/or treatment time settings, the operator or the system may cease thedelivery of ablation means 104′ to the middle of the tooth bud 130 b.The ablation probe tip 232 may then be removed. The monitoring andoverride safeguards described herein are preferably used in this step.

It should be noted that the order of these steps is meant to beexemplary and is not meant to be limiting. For example, the parametersetting step 300 may be performed before or after the calibrating step302 and/or anesthetizing step 304. Similarly, the calibrating step 302may be performed before or after the anesthetizing step 304. Also, someof the steps are optional or may be performed separate from the TBAprocedure. For example, if the patient was anesthetized for anotherprocedure, the anesthetizing step 304 would not be necessary.

Alternative Procedures and Systems

Separate preferred surgical procedures preferably include the ablationof “non-tooth” bud lesions or tumors of the maxilla or mandible. In sucha situation, a custom stent would be manufactured or fabricated withguides to guide an ablation probe tip 108 to such a lesion or tumorlocated at least one lesion or tumor surgical site. The process couldthen be used to ablate such lesion or tumor.

Separate TBA surgical procedures preferably include the use ofultrasound scanning with combined ultra-high energy ultrasound ablationbut without the use of a surgical stent for transgingival tooth budablation that results in tooth agenesis. This can be described as directultrasound scanning with ultra-high energy ultrasound built into thesame scanning head.

Comparison to the Silvestri Study

As set forth in the Background section of this document, the articleentitled “Selectively Preventing Development Of Third Molars In RatsUsing Electrosurgical Energy” by Silvestri et al. describes a pilotstudy that tests the hypothesis that third molars can be selectivelyprevented from developing. The results of the Silvestri study were mixedat best, with only ten rats out of thirty-three showing the desiredresult of no intraoral or radiographic evidence of third molardevelopment. One reason that the Silvestri process was not successfulmay have had to do with the fact that the Silvestri process was inexact.For example, the Silvestri process relied on molds taken from molds ofthe mouths of euthanized rat pups rather than using molds fabricated forthe rat pup on which the procedure was to be performed. The presentinvention uses the patient's mouth on which the procedure is to beperformed. Another way in which the Silvestri process was inexact wasthat the Silvestri process did not locate the forming tooth bud 120.More specifically, the Silvestri process did not locate or determine thelocation of the forming tooth bud 120 pre-operatively relative to thelandmarks that he used. Silvestri even states “ . . . whenelectrosurgical energy is applied near the invisible tooth anlage in thetiny mouth of newborn rats, the effects of the electrosurgical energycannot be nearly as local or precise. The embryonic tooth-formingtissues of the third molar [lay] fractions of a millimeter below theoral mucosa and cannot be seen. As a result, it was not possible topredictably protect and isolate the vulnerable developing bone from theenergy and heat of the electrosurgical energy. The result was arelatively large, unpredictable area of tissue damage during treatmentand a wide range of bony developmental effects seen after the rats wereeuthanized.” The TBA procedure 70 described herein can be distinguishedfrom the Silvestri procedure in several ways including for example, that(1) the TBA procedure 70 described herein is a minimally invasiveprocedure consisting of introducing a surgical access path at each toothbud surgical site as opposed to the boring, killing, and damagingprocedure described by Silvestri, (2) the TBA procedure 70 describedherein is performed in such a manner that it can be described as exact(e.g. using the patient's mouth as the mold for manufacturing orfabricating the surgical stent 110, taking exact measurements of thepatient's mouth (including the position of the tooth bud 120), and usingcalculated parameter and time settings 105 b) as opposed to theSilvestri procedure that can be described as inexact, and (3) the TBAprocedure 70 described herein can predictably ablate tooth buds 120 asopposed to the Silvestri procedure that was essentially unpredictableand could never, under any circumstances, be considered for treatinghuman patients.

Flow Charts

FIGS. 4, 11, 12, and 40 are flow charts illustrating processes, methods,and/or systems. It will be understood that at least some of the blocksof these flow charts, components of all or some of the blocks of theseflow charts, and/or combinations of blocks in these flow charts, may beimplemented by software (e.g. coding, computer program instructions,software programs, subprograms, or other series of computer-executableor processor-executable instructions), by hardware (e.g. processors,memory), by firmware, and/or a combination of these forms. As anexample, in the case of software, computer program instructions(computer-readable program code) may be loaded onto a computer (or on aspecial purpose machine such as a volume scanner or scanning technology)to produce a machine, such that the instructions that execute on thecomputer create structures for implementing the functions specified inthe flow chart block or blocks. These computer program instructions mayalso be stored in a memory that can direct a computer to function in aparticular manner, such that the instructions stored in the memoryproduce an article of manufacture including instruction structures thatimplement the function specified in the flow chart block or blocks. Thecomputer program instructions may also be loaded onto a computer (or ona special purpose machine such as a volume scanner or scanningtechnology) to cause a series of operational steps to be performed on orby the computer to produce a computer implemented process such that theinstructions that execute on the computer provide steps for implementingthe functions specified in the flow chart block or blocks. The term“loaded onto a computer” also includes being loaded into the memory ofthe computer or a memory associated with or accessible by the computer(or on a special purpose machine such as a volume scanner or scanningtechnology). The term “memory” is defined to include any type ofcomputer (or other technology)-readable media including, but not limitedto, attached storage media (e.g. hard disk drives, network disk drives,servers), internal storage media (e.g. RAM, ROM), removable storagemedia (e.g. CDs, DVDs, flash drives, memory cards, floppy disks), and/orother storage media known or yet to be discovered. The term “computer”is meant to include any type of processor, programmable logic device, orother type of programmable apparatus known or yet to be discovered.Accordingly, blocks of the flow charts support combinations of steps,structures, and/or modules for performing the specified functions. Itwill also be understood that each block of the flow charts, andcombinations of blocks in the flow charts, may be divided and/or joinedwith other blocks of the flow charts without affecting the scope of theinvention. This may result, for example, in computer-readable programcode being stored in whole on a single memory, or various components ofcomputer-readable program code being stored on more than one memory.

Additional Information

It is to be understood that the inventions, examples, and embodimentsdescribed herein are not limited to particularly exemplified materials,methods, and/or structures. Further, all publications, patents, andpatent applications cited herein, whether supra or infra, are herebyincorporated by reference in their entirety.

Please note that the terms and phrases may have additional definitionsand/or examples throughout the specification. Where otherwise notspecifically defined, words, phrases, and acronyms are given theirordinary meaning in the art. The following paragraphs provide some ofthe definitions for terms and phrases used herein.

-   -   The terms “fabricating” and/or “manufacturing” include any        suitable means of making a component (e.g. stent 110). Although        the terms are used together throughout most of the specification        (e.g. “manufacturing or fabricating”), the absence of one term        or another is irrelevant because they are used herein        synonymously.    -   The terms “proper,” “correct,” “optimal,” and “ideal,” are        relative and may become more accurate as technology is        developed. For example, when used in terms of the pre-defined        angle (ϕ) and pre-defined depth (x) that are calculated and/or        prescribed (e.g. the “proper angle and depth,” the “correct        angle and depth,” the “optimal angle and depth,” or the “ideal        angle and depth”), these phrases are meant to include the best        possible angle and depth that is calculated using the best        available information and technology.    -   The terms “provide” and “providing” (and variations thereof) are        meant to include standard means of provision including        “transmit” and “transmitting,” but can also be used for        non-traditional provisions as long as the data is “received”        (which can also mean obtained). The terms “transmit” and        “transmitting” (and variations thereof) are meant to include        standard means of transmission, but can also be used for        non-traditional transmissions as long as the data is “sent.” The        terms “receive” and “receiving” (and variations thereof) are        meant to include standard means of reception, but can also be        used for non-traditional methods of obtaining as long as the        data is “obtained.”

It should be noted that the terms “may” and “might” are used to indicatealternatives and optional features and only should be construed as alimitation if specifically included in the claims. It should be notedthat the various components, features, steps, phases, or embodimentsthereof are all “preferred” whether or not it is specifically indicated.Claims not including a specific limitation should not be construed toinclude that limitation.

It should be noted that, unless otherwise specified, the term “or” isused in its nonexclusive form (e.g. “A or B” includes A, B, A and B, orany combination thereof, but it would not have to include all of thesepossibilities). It should be noted that, unless otherwise specified,“and/or” is used similarly (e.g. “A and/or B” includes A, B, A and B, orany combination thereof, but it would not have to include all of thesepossibilities). It should be noted that, unless otherwise specified, theterm “includes” means “comprises” (e.g. a device that includes orcomprises A and B contains A and B but optionally may contain C oradditional components other than A and B). It should be noted that,unless otherwise specified, the singular forms “a,” “an,” and “the”refer to one or more than one, unless the context clearly dictatesotherwise.

The terms and expressions that have been employed in the foregoingspecification are used as terms of description and not of limitation,and are not intended to exclude equivalents of the features shown anddescribed. This application is intended to cover any adaptations orvariations of the present invention. It will be appreciated by those ofordinary skill in the art that any arrangement that is calculated toachieve the same purpose may be substituted for the specific embodimentshown. It is also to be understood that the following claims areintended to cover all of the generic and specific features of theinvention herein described and all statements of the scope of theinvention which, as a matter of language, might be said to falltherebetween.

What is claimed is:
 1. A system including an ablation probe tip and avirtual stent, said ablation probe tip for use in an ablation procedurethat results in tissue agenesis, said ablation probe tip for use with anablation probe unit, said system comprising: (a) said ablation probe tiphaving a shaft, said shaft having an insertion end for inserting intotissue and a connection end for connecting said ablation probe tip tosaid ablation probe unit, said ablation probe tip having a center ofablation; (b) said virtual stent having a display, said ablation probetip being guidable at a pre-defined angle when used in conjunction withsaid virtual stent, said pre-defined angle being a three-dimensionalangle; (c) said ablation probe tip being depth limited by at least onestop indicator to a pre-defined depth; and (d) a representation of saidablation probe tip being displayed on said display, said ablation probetip being guidable at said pre-defined angle by virtual surgical guideangle markings displayed on said display; wherein said center ofablation is within tissue to be ablated when said ablation probe tip isguided at said pre-defined angle to said pre-defined depth.
 2. Thesystem of claim 1, wherein said ablation probe tip is a sensoredablation probe tip.
 3. The system of claim 1, wherein said ablationprobe tip is a sensored ablation probe tip having a movement sensor. 4.The system of claim 1, said center of ablation positioned between saidinsertion end and said connection end.
 5. The system of claim 1, saidablation probe tip being depth limited by stop information to apre-defined depth, said stop information being provided by a visualindicator.
 6. The system of claim 1, said ablation probe tip being depthlimited by stop information to a pre-defined depth, said stopinformation being provided by an audible indicator.
 7. The system ofclaim 1, said ablation probe tip being depth limited by stop informationto a pre-defined depth, said stop information being provided by atactile indicator.
 8. The system of claim 1, said ablation probe tipbeing depth limited by stop information to a pre-defined depth, saidstop information being provided by a combination of at least twoindicators selected from selected from the group consisting of: (a) avisual indicator; (b) an audible indicator; and (c) a tactile indicator.9. The system of claim 1, wherein said ablation procedure that resultsin tissue agenesis is a tooth bud ablation procedure that results intooth agenesis by inserting said insertion end into a tooth bud.
 10. Asystem including a ablation probe tip and a virtual stent, said ablationprobe tip for use in an ablation procedure that results in tissueagenesis, said ablation probe tip for use with an ablation probe unit,said system comprising: (a) said ablation probe tip having a shaft, saidshaft having an insertion end for inserting into tissue and a connectionend for connecting said ablation probe tip to said ablation probe unit,said ablation probe tip having a center of ablation; (b) said virtualstent having a display, said ablation probe tip being guidable at apre-defined angle when used in conjunction with said virtual stent; and(c) a representation of said ablation probe tip being displayed on saiddisplay, said ablation probe tip being guidable at said pre-definedangle by virtual surgical guide angle markings displayed on saiddisplay.
 11. The system of claim 7, wherein said ablation probe tip is asensored ablation probe tip.
 12. The system of claim 7, wherein saidablation probe tip is a sensored ablation probe tip having a movementsensor.
 13. The system of claim 7, wherein said ablation procedure thatresults in tissue agenesis is a tooth bud ablation procedure thatresults in tooth agenesis by inserting said insertion end into a toothbud.
 14. The system of claim 7, said ablation probe tip being depthlimited by stop information to a pre-defined depth, said stopinformation being provided by a visual indicator.
 15. The system ofclaim 7, said ablation probe tip being depth limited by stop informationto a pre-defined depth, said stop information being provided by anaudible indicator.
 16. The system of claim 7, said ablation probe tipbeing depth limited by stop information to a pre-defined depth, saidstop information being provided by a tactile indicator.
 17. The systemof claim 7, said ablation probe tip being depth limited by stopinformation to a pre-defined depth, said stop information being providedby a combination of at least two indicators selected from selected fromthe group consisting of: (a) a visual indicator; (b) an audibleindicator; and (c) a tactile indicator.